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Monoclonal Antibodies

Part D: Optional DDI for Human Immunodeficiency Virus Infection

Phase 1
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Participants who are overtly healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
2. Participants who can understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days (d) 1 to 5, 8, 15, 25 for cohort a1 (part a), d 1 to 6, 9, 15, 25 for cohort a2 (part a), d 1 to 7, 10, 18, 30 for cohort a3 (part a), at d 1, 3, 6, 12,15 for part b, at d 1, 2, 8, 9, 13 to 17, 42 for part c, at d 1, 3, 10, 14, 28 for part d
Awards & highlights

Summary

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.

Who is the study for?
This trial is for healthy volunteers who can help test the safety and how the body processes a new drug, VH3739937. Specific details on eligibility criteria are not provided, but typically participants must meet certain health standards.
What is being tested?
The study tests different doses of VH3739937 (100 mg to 500 mg) in various parts with some receiving a placebo or other treatments for comparison. It also looks at how food and other drugs might affect VH3739937.
What are the potential side effects?
Since this is an early-phase trial for a new drug, exact side effects aren't listed but generally could include reactions at the site of administration, nausea, headaches, or more serious issues depending on the drug's action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 1 to 6, 8, 11, 15, 20, 25 (cohort a1), at days 1, 3 to 9, 11, 15, 20, 25 (cohort a2), at days 1, 4 to 8 , 10, 14, 18, 25, day 30 (cohort a3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 1 to 6, 8, 11, 15, 20, 25 (cohort a1), at days 1, 3 to 9, 11, 15, 20, 25 (cohort a2), at days 1, 4 to 8 , 10, 14, 18, 25, day 30 (cohort a3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Number of participants with adverse events (AEs) by grade of severity
Part A: Number of participants with any adverse events (AEs)
Part A: Number of participants with any serious adverse events (SAEs)
+17 more
Secondary study objectives
Categorical outliers for heart rate, PR Interval, QRS Interval and QT Interval over all study groups
Change from baseline for heart rate over all study groups
Change from baseline in PR Interval, QRS Interval, and QT Interval corrected for heart rate using Fridericias formula (QTcF) over all study groups
+29 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part D: Optional DDIExperimental Treatment2 Interventions
Participants in this group will receive a dose of the probe cocktail (Midazolam, Digoxin, Total Dabigatran etexilate, Rosuvastatin) alone on Day 1, followed by a subsequent dose of probe cocktail together with a single dose of VH3739937 on Day 10, in fed conditions.
Group II: Part C: Optional QW VH3739937Experimental Treatment1 Intervention
Participants in this group will receive a weekly administration (QW) of VH3739937 during a 3-week period in fed conditions.
Group III: Part B RBA/ optional FE: VH3739937Experimental Treatment5 Interventions
Part B RBA/FE: VH3739937 group will include participants that will receive treatment sequences (Treatment AB or BA) alternatively in Period 1 and Period 2 of the treatment. In Period 3 and Period 4, participants will receive 1 of 6 treatment sequences (CD, CE, ED, EC, DE, DC) in fed or fasted conditions.
Group IV: Part A MAD: VH3739937Experimental Treatment2 Interventions
Part A MAD: VH3739937 group will contain 3 ascending repeat-dose cohorts (Cohorts A1- A3), where participants will receive a twice daily (BID) dose of VH3739937 for 1 (Cohort A1), 2 (Cohort A2) or 3 (Cohort A3) days in fed conditions.
Group V: Part A MAD: PlaceboPlacebo Group1 Intervention
Part A MAD: Placebo group will include participants that will receive BID dose of placebo in fed conditions
Group VI: Part C: Optional QW PlaceboPlacebo Group2 Interventions
Participants in this group will receive a weekly administration (QW) of placebo during a 3-week period in fed conditions.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
366 Previous Clinical Trials
469,078 Total Patients Enrolled
~61 spots leftby Mar 2025
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