PainPhase 1NCT05174013

Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants

A Phase 1 study testing GSK3858279 in people with Pain, run by GlaxoSmithKline at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy Caucasian, Chinese and Japanese participants. Read more about this study

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: GSK3858279
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 2 sitesAustralia
Study dates: 14 Feb 2022to 17 Apr 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive).
Japanese participants are eligible based on meeting all of the following:

Show all 19Show fewer

Participants born in Japan
Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents.
Have lived outside Japan for less than (<) 10 years at the time of screening
Chinese participants are eligible based on meeting all of the following
Participants born in mainland China, Hong Kong or Taiwan
Descendants of four Chinese grandparents and two Chinese parents
Have lived outside China, Hong Kong or Taiwan for <10 years at the time of screening
Caucasian participants are eligible based on meeting the following
Declaration of familial Caucasian/European ancestry (having 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry)
Male or female participant
Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
A female participant is eligible to participate if she is of non-reproductive potential.
Capable of giving signed informed consent.

Who cannot join

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Personal or family history of cardiomyopathy.
Abnormal blood pressure at screening as determined by the investigator.
History of symptomatic herpes zoster.
Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
Significant allergies to humanized monoclonal antibodies as per principal investigator's and GSK medical monitor's judgements.

Show all 37Show fewer

History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
History of lymphoma, leukaemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
ALT greater than (>)1.5 times upper limit of normal (ULN) .
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT (QTc) >450 milliseconds (msec).
History of Stevens Johnson Syndrome.
Known immunodeficiency.
Participants with a chronic infection (for example [e.g.], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders.
History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments.
Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit.
Live vaccine(s) or plans to receive such vaccines within 1 month of screening until final follow-up visit.
Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
Major surgery (as per investigator's judgement) within 3 months prior to dosing.
Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation in any other clinical study involving an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing the ICF.
Presence of Hepatitis B surface antigen (HBsAg) at screening.
Presence of the Hepatitis B core antibody (HBcAb) at screening.
Positive Hepatitis C antibody test result at screening.
Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction (PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab only.
Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 units for males and >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Regular use of known drugs of abuse.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

GSK Investigational Site
Herston Queensland, Queensland, 4006
GSK Investigational Site
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants

Conditions: Pain
Being tested: GSK3858279, Placebo
Keywords: Pharmacokinetics, Safety, Tolerability, GSK3858279, Placebo, Caucasian, Chinese, Japanese
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK3858279Drug
GSK3858279 will be administered
PlaceboDrug
Placebo will be administered

Study groups in NCT05174013
Study group	Role	What they receive
GSK3858279 Caucasian	Experimental	Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants. Receives: Drug: GSK3858279
GSK3858279 Chinese	Experimental	Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants. Receives: Drug: GSK3858279
GSK3858279 Japanese	Experimental	Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants. Receives: Drug: GSK3858279
Caucasian Placebo	Placebo comparator	Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants. Receives: Drug: Placebo
Chinese Placebo	Placebo comparator	Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants. Receives: Drug: Placebo
Japanese Placebo	Placebo comparator	Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.
Measured: Up to 169 days
Change From Baseline in Hematology Parameter of Platelet Count
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Total Protein
Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin
Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine
Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium
Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Measured: Baseline and Day 169
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Measured: Baseline and Day 169
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Measured: Baseline and Day 169
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Vital Signs: Pulse Rate
The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Vital Signs: Body Temperature
The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Vital Signs: Respiratory Rate
The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline and Day 169
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Measured: Baseline and Day 169
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Measured: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Measured: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Measured: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Maximum Observed Concentration (Cmax) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Measured: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Time of Occurrence of Cmax (Tmax) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Measured: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days

Secondary outcomes (7)

Percentage Change From Baseline in Free CCL17
Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Measured: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Cmax of Total CCL17 in Serum Following GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Measured: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Tmax of Total CCL17 in Serum Following GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Measured: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Measured: Baseline (Day 1) and Days 56 Post dose
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Measured: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)
Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Measured: Day 169
Number of Participants With Treatment-Emergent ADA's Over Time
Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Measured: Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202217 Apr 2023

First posted30 Dec 2021
Study start14 Feb 2022
Primary completion10 Feb 2023
Study completion17 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05174013
Sponsor's protocol ID: 212979
Status last verified: May 2025
First submitted: 22 Dec 2021
Last updated: 15 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants
ClinicalTrials.gov ID: NCT05174013
Acronym / sponsor ID: 212979
Conditions: Pain
Keywords: Pharmacokinetics, Safety, Tolerability, GSK3858279, Placebo, Caucasian, Chinese, Japanese
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Feb 2022 (actual)
Primary completion: 10 Feb 2023 (actual)
Study completion: 17 Apr 2023 (actual)
First posted: 30 Dec 2021 (actual)
Results: Posted 15 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
GSK3858279 Caucasian	Experimental	Drug: GSK3858279Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
GSK3858279 Chinese	Experimental	Drug: GSK3858279Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
GSK3858279 Japanese	Experimental	Drug: GSK3858279Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Caucasian Placebo	Placebo comparator	Drug: PlaceboParticipants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
Chinese Placebo	Placebo comparator	Drug: PlaceboParticipants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
Japanese Placebo	Placebo comparator	Drug: PlaceboParticipants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive).

Key exclusion criteria (37 listed)

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Personal or family history of cardiomyopathy.
Abnormal blood pressure at screening as determined by the investigator.
History of symptomatic herpes zoster.
Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK3858279GSK3858279 will be administered	Drug	GSK3858279 Caucasian, GSK3858279 Chinese, GSK3858279 Japanese
PlaceboPlacebo will be administered	Drug	Caucasian Placebo, Chinese Placebo, Japanese Placebo

Primary outcome

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's
Time frame: Up to 169 days
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.
Change From Baseline in Hematology Parameter of Platelet Count
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Hematology Parameter of Hemoglobin
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Hematology Parameter of Hematocrit
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Total Protein
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium
Time frame: Baseline and Day 169
Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)
Time frame: Baseline and Day 169
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)
Time frame: Baseline and Day 169
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
Time frame: Baseline and Day 169
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Baseline and Day 169
The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Vital Signs: Pulse Rate
Time frame: Baseline and Day 169
The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Vital Signs: Body Temperature
Time frame: Baseline and Day 169
The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Vital Signs: Respiratory Rate
Time frame: Baseline and Day 169
The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval
Time frame: Baseline and Day 169
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279
Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279
Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279
Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Maximum Observed Concentration (Cmax) of GSK3858279
Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Time of Occurrence of Cmax (Tmax) of GSK3858279
Time frame: Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.

7 secondary outcomes

Percentage Change From Baseline in Free CCL17
Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Cmax of Total CCL17 in Serum Following GSK3858279
Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Tmax of Total CCL17 in Serum Following GSK3858279
Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration
Time frame: Baseline (Day 1) and Days 56 Post dose
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration
Time frame: Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)
Time frame: Day 169
Number of Participants With Treatment-Emergent ADA's Over Time
Time frame: Day 169

Results and safety

Results posted to the registry on 15 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK3858279 Caucasian	6	6
GSK3858279 Chinese	7	7
GSK3858279 Japanese	7	6
Caucasian Placebo	4	3
Chinese Placebo	3	3
Japanese Placebo	4	4

Primary outcome: Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's

Time frame: Up to 169 days. Count of participants. Unit: Participants

Measure	GSK3858279 Caucasian n = 6	GSK3858279 Chinese n = 7	GSK3858279 Japanese n = 7	Caucasian Placebo n = 4	Chinese Placebo n = 3	Japanese Placebo n = 4
AE	5	6	2	4	1	2
SAE	0	0	0	0	0	0
Withdrawals Due to AE	0	0	0	0	0	0

Population analysed: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Primary outcome: Change From Baseline in Hematology Parameter of Platelet Count

Time frame: Baseline and Day 169. Mean (Standard Deviation). Unit: Giga cells per liter (10^9/L)

Measure	GSK3858279 Caucasian n = 6	GSK3858279 Chinese n = 7	GSK3858279 Japanese n = 7	Caucasian Placebo n = 4	Chinese Placebo n = 3	Japanese Placebo n = 4
Value	2.8 (25.90)	18.0 (18.81)	-4.2 (12.27)	7.0 (15.59)	16.0 (39.60)	-12.3 (6.51)

Population analysed: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Primary outcome: Change From Baseline in Hematology Parameter of Hemoglobin

Time frame: Baseline and Day 169. Mean (Standard Deviation). Unit: Gram Per Liter (g/L)

Measure	GSK3858279 Caucasian n = 6	GSK3858279 Chinese n = 7	GSK3858279 Japanese n = 7	Caucasian Placebo n = 4	Chinese Placebo n = 3	Japanese Placebo n = 4
Value	-7.5 (13.79)	-6.0 (10.42)	-2.0 (10.79)	-5.3 (7.37)	-10.5 (16.26)	-3.0 (3.61)

Population analysed: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

Primary outcome: Change From Baseline in Hematology Parameter of Hematocrit

Time frame: Baseline and Day 169. Mean (Standard Deviation). Unit: Liter/liter (L/L)

Measure	GSK3858279 Caucasian n = 6	GSK3858279 Chinese n = 7	GSK3858279 Japanese n = 7	Caucasian Placebo n = 4	Chinese Placebo n = 3	Japanese Placebo n = 4
Value	-0.027 (0.0367)	-0.010 (0.0408)	-0.005 (0.0259)	-0.027 (0.0321)	-0.035 (0.0495)	-0.013 (0.0208)

Population analysed: The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs and SAEs were collected from the start of the study intervention up to Day 169.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK3858279 Caucasian	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
GSK3858279 Chinese	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
GSK3858279 Japanese	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Caucasian Placebo	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Chinese Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Japanese Placebo	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Pain

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK3858279 in people with Pain, run by GlaxoSmithKline at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's (time frame: Up to 169 days). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.