HIV InfectionsPhase 1SPANNCT05291520
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
A Phase 1 study testing VH3810109 and rHuPH20 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH3810109 and rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 10 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria.
- Participants having body weight of ≥50 kilogram (kg) and <100 kg
- Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening.
- Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants who are female at birth are eligible to participate if at least one of the following conditions applies:
- Not pregnant or breastfeeding and at least one of the following conditions applies:
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- Is not a participant of childbearing potential (POCBP) or Is a POCBP and agree to use an acceptable contraceptive method as described in Section 10.4 from 3 weeks prior to the start of this study and during the study. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- A POCBP must have a negative highly sensitive serum pregnancy test on Day -1, prior to the first dose of study intervention All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom).
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
- Capable of giving written informed consent.
Who cannot join
- Hypertension that is not well controlled.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.
- Positive human immunodeficiency virus (HIV) antibody test.
- Positive test result for SARS-CoV-2.
- Evidence of hepatitis B (HB) virus infection at screening or within 3 months prior to first dose of study intervention Participants positive for Hepatitis B antigen (HBsAg) are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for Hepatitis B virus (HBV) DNA are excluded
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
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- The participant has an underlying skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) or tattoos that would interfere with assessment of injection sites.
- History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
- 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, dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Exposure to an experimental drug, human blood product, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment OR plans to receive live vaccines during the study.
- Prior receipt of licensed or investigational Monoclonal antibody (Mab).
- Receipt of any investigational study agent within 28 days prior to first dose of study treatment
- Prior exposure to VH3810109 or rHuPH20 in this or another clinical study.
- Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- ALT ≥1.5 times the upper limit of normal (ULN).
- Total bilirubin ≥1.5 times the ULN (isolated total bilirubin >1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%).
- 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 interval Fridericia's formula (QTcF)>450 millisecond (msec) for males and QTcF >470 msec for females.
- The participant has a tattoo or other dermatological condition overlying potential injection sites that may interfere with interpretation of ISRs or administration of VH3810109.
- Grade 4 laboratory abnormalities.
- Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
- Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZ Drug Product (EDP)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.
- Conditions
- HIV Infections
- Being tested
- VH3810109, rHuPH20
- Keywords
- VH3810109, GSK3810109, HIV, Human Monoclonal Antibody, rHuPH20, Pharmacokinetics, Safety, Tolerability, N6LS
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH3810109Biological
VH3810109 was administered.
rHuPH20Biological
rHuPH20 was administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Experimental | Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. Receives: Biological: VH3810109; Biological: rHuPH20 |
| Part 2 Group: VH3810109 60 mg/kg [IV] | Experimental | Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks. Receives: Biological: VH3810109 |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Experimental | Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. Receives: Biological: VH3810109; Biological: rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)
An AE is 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. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
Measured: Up to Week 24
Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
Measured: Up to Week 24
Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)
ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.
Measured: Up to 7 days post-dose
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3)
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
Measured: Up to Week 24
Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)
An AE is 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. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
Measured: Up to Week 24
Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
Measured: Up to Week 24
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
Measured: Up to Week 24
Secondary outcomes (27)
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109
Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis of VH3810109.
Measured: Up to Week 24
AUC From Time Zero to Time t (AUC[0-t]) of VH3810109
Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Measured: Up to Week 24
Maximum Observed Concentration (Cmax) of VH3810109
Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Measured: Up to Week 24
Time of Maximum Observed Concentration (Tmax) of VH3810109
Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Measured: Up to Week 24
Apparent Terminal Phase Half-life (t1/2) of VH3810109
Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.
Measured: Up to Week 24
Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.
Measured: At Day 2 and Day 7
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.
Scores range from 1 to 5; the scores are defined as following: 1=not at all bothered, 2=a little bothered, 3=moderately bothered, 4=very bothered, 5=extremely bothered; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.
Measured: At Day 2 and Day 7
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3)
The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.
Scores range from 1 to 5; the scores are defind as following: 1=totaly acceptable, 2=very acceptable, 3=moderately acceptable, 4=a little acceptable, 5=not at all acceptable; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.
Measured: At Day 2 and Day 7
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)
Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: At Day 1, Day 2 and Day 7
Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)
Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: At Day 1, Day 2 and Day 7
Number of ISRs Events Overall and by Grade (Part 1 and 3)
ISRs were recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity was categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated, Grade 5 (death). Higher grade indicates more severe condition.
Measured: Up to day 14
The Overall Duration of ISRs, Expressed in Days
ISRs will be recorded via ISR diaries and managed through investigator assessment.
Measured: From Day 1 up to Day 14
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Hematocrit
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Hemoglobin, Albumin and Total Protein
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Red Blood Cell Count (RBC)
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Mean Corpuscle Volume (MCV)
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.
Measured: From Baseline (Day -1) up to Week 24
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline
Urine samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. At baseline and post-baseline, worst case urinalysis data was determined by comparing the resulted values of the urinalysis for each participant to the normal rage. This endpoint evaluates the changes from baseline for the worst case urinalysis.
Measured: Day 14 compared with baseline (Day -1)
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
ECG values were collected as assessed by protocol, at the indicated time points.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Temperature
Temperature was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Pulse Rate
Pulse rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Respiratory Rate
Respiratory rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.
Measured: From Baseline (Day -1) up to Week 24
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.
Measured: From Baseline (Day -1) up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start23 Feb 2022
- Primary completion10 Apr 2023
- Study completion10 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291520
- Sponsor's protocol ID
- 217901
- Acronym
- SPAN
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.
PubMed 40698814
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults
- ClinicalTrials.gov ID
- NCT05291520
- Acronym / sponsor ID
- SPAN / 217901
- Conditions
- HIV Infections
- Keywords
- VH3810109, GSK3810109, HIV, Human Monoclonal Antibody, rHuPH20, Pharmacokinetics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20
| Arm | Type | Receives |
|---|---|---|
| Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC] | Experimental | Biological: VH3810109, Biological: rHuPH20Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. |
| Part 2 Group: VH3810109 60 mg/kg [IV] | Experimental | Biological: VH3810109Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks. |
| Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] | Experimental | Biological: VH3810109, Biological: rHuPH20Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria.
- Participants having body weight of ≥50 kilogram (kg) and <100 kg
- Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening.
- Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants who are female at birth are eligible to participate if at least one of the following conditions applies:
Key exclusion criteria (23 listed)
- Hypertension that is not well controlled.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.
- Positive human immunodeficiency virus (HIV) antibody test.
- Positive test result for SARS-CoV-2.
- Evidence of hepatitis B (HB) virus infection at screening or within 3 months prior to first dose of study intervention Participants positive for Hepatitis B antigen (HBsAg) are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for Hepatitis B virus (HBV) DNA are excluded
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 |
|---|---|---|
| VH3810109VH3810109 was administered. | Biological | Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC], Part 2 Group: VH3810109 60 mg/kg [IV], Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] |
| rHuPH20rHuPH20 was administered. | Biological | Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC], Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC] |
Primary outcome
Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)
Time frame: Up to Week 24
An AE is 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. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)
Time frame: Up to Week 24
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)
Time frame: Up to 7 days post-dose
ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.
Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3)
Time frame: Up to Week 24
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)
Time frame: Up to Week 24
An AE is 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. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.
Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)
Time frame: Up to Week 24
An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.
Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)
Time frame: Up to Week 24
Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.
27 secondary outcomes
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109
Time frame: Up to Week 24
AUC From Time Zero to Time t (AUC[0-t]) of VH3810109
Time frame: Up to Week 24
Maximum Observed Concentration (Cmax) of VH3810109
Time frame: Up to Week 24
Time of Maximum Observed Concentration (Tmax) of VH3810109
Time frame: Up to Week 24
Apparent Terminal Phase Half-life (t1/2) of VH3810109
Time frame: Up to Week 24
Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)
Time frame: At Day 2 and Day 7
Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)
Time frame: At Day 2 and Day 7
Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3)
Time frame: At Day 2 and Day 7
Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)
Time frame: At Day 1, Day 2 and Day 7
Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)
Time frame: At Day 1, Day 2 and Day 7
Number of ISRs Events Overall and by Grade (Part 1 and 3)
Time frame: Up to day 14
The Overall Duration of ISRs, Expressed in Days
Time frame: From Day 1 up to Day 14
Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Hematocrit
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Hemoglobin, Albumin and Total Protein
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Red Blood Cell Count (RBC)
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Mean Corpuscle Volume (MCV)
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)
Time frame: From Baseline (Day -1) up to Week 24
Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline
Time frame: Day 14 compared with baseline (Day -1)
Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Temperature
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Pulse Rate
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Respiratory Rate
Time frame: From Baseline (Day -1) up to Week 24
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: From Baseline (Day -1) up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40698814Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
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 VH3810109 and rHuPH20 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
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 10 inclusion and 23 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 19 Sep 2024. 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 States. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). 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 Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3) (time frame: Up to Week 24). The study lists 7 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 NCT05291520, which also lists 1 linked publication.
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 19 Sep 2024.