RecruitingPhase 1

First Time in Human Study of Long Acting VH4524184 Formulations

United States268 participantsStarted 2024-03-21

Plain-language summary

The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
✓. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
✓. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
✓. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
✓. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except A11. For Cohort A11, body mass index within the range \>32.0 to 37.0 kg/m\^2 (inclusive).
✓. Male or female
✓. Male Participants: No restrictions for male participants
✓. Participants of female sex assigned at birth:

Exclusion criteria

✕. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
✕. Clinically significant abnormal blood pressure as determined by the investigator.

What they're measuring

Percentage of participants reporting adverse events (AEs) and related AEs

Timeframe: From first study dose administration (Day 1) up to study end (Week 52 post last dose)

Percentage of participants with AEs by severity

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Percentage of participants discontinuing the treatment due to AEs

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Change from baseline in total bilirubin parameters

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Change from baseline in international normalized ratio (INR) parameters

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Maximum toxicity grade increase from baseline in ALT, AST and alkaline phosphatase

Trial details

NCT IDNCT06310551

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-21

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
✓. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
✓. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
✓. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
✓. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except A11. For Cohort A11, body mass index within the range \>32.0 to 37.0 kg/m\^2 (inclusive).
✓. Male or female
✓. Male Participants: No restrictions for male participants
✓. Participants of female sex assigned at birth:

Exclusion criteria

✕. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
✕. Clinically significant abnormal blood pressure as determined by the investigator.

What they're measuring

Percentage of participants reporting adverse events (AEs) and related AEs

Timeframe: From first study dose administration (Day 1) up to study end (Week 52 post last dose)

Percentage of participants with AEs by severity

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Percentage of participants discontinuing the treatment due to AEs

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Change from baseline in total bilirubin parameters

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Change from baseline in international normalized ratio (INR) parameters

Timeframe: From first dose administration (Day 1) up to study end (Week 52 post last dose)

Maximum toxicity grade increase from baseline in ALT, AST and alkaline phosphatase