Pulmonary Disease, Chronic ObstructivePhase 1NCT07789899
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants
A Phase 1 study testing GSK3862995B in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK3862995B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2026to 7 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring
- Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
- Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m^2) (inclusive)
- Male, or female of non-childbearing potential (PONCBP)
Who cannot join
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
- Abnormal blood pressure (as determined by the investigator)
- Symptomatic herpes zoster within 3 months prior to screening
- Significant allergies to humanized monoclonal antibodies
- 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)
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- Lymphoma, leukemia, or any malignancy within the past 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
- Breast cancer within the past 10 years
- Alanine transaminase (ALT) greater than (>)1.0x upper limit of normal (ULN)
- Total bilirubin >1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is less than or equal to (<=) 1.5 x ULN
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- A clinically significant abnormality in the average of triplicate 12-lead ECG readings performed at screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Cambridge, CB2 2GG
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1, Open-Label, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations After a Single Dose in Healthy Participants
This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK3862995B
- Keywords
- GSK3862995B, Pharmacokinetics, Healthy Volunteers, Phase 1, Safety and Tolerability
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3862995BDrug
GSK3862995B will be administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK3862995B Formulation A | Experimental | Healthy participants will receive GSK3862995B Formulation A. Receives: Drug: GSK3862995B |
| GSK3862995B Formulation B | Experimental | Healthy participants will receive GSK3862995B Formulation B. Receives: Drug: GSK3862995B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B
Measured: From pre-dose on Day 1 through Week 36
Maximum Observed Serum Concentration (Cmax) of GSK3862995B
Measured: From pre-dose on Day 1 through Week 36
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 49
Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start18 Aug 2026
- Primary completion7 Sep 2027 (estimated)
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789899
- Sponsor's protocol ID
- 301202
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations After a Single Dose in Healthy Participants
- ClinicalTrials.gov ID
- NCT07789899
- Acronym / sponsor ID
- 301202
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GSK3862995B, Pharmacokinetics, Healthy Volunteers, Phase 1, Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 7 Sep 2027 (estimated)
- Study completion
- 7 Sep 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK3862995B Formulation A | Experimental | Drug: GSK3862995BHealthy participants will receive GSK3862995B Formulation A. |
| GSK3862995B Formulation B | Experimental | Drug: GSK3862995BHealthy participants will receive GSK3862995B Formulation B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring
- Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
- Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m^2) (inclusive)
- Male, or female of non-childbearing potential (PONCBP)
Key exclusion criteria (12 listed)
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
- Abnormal blood pressure (as determined by the investigator)
- Symptomatic herpes zoster within 3 months prior to screening
- Significant allergies to humanized monoclonal antibodies
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 |
|---|---|---|
| GSK3862995BGSK3862995B will be administered. | Drug | GSK3862995B Formulation A, GSK3862995B Formulation B |
Primary outcome
Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B
Time frame: From pre-dose on Day 1 through Week 36
Maximum Observed Serum Concentration (Cmax) of GSK3862995B
Time frame: From pre-dose on Day 1 through Week 36
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 49
Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings
Time frame: Up to Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3862995B in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B (time frame: From pre-dose on Day 1 through Week 36). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.