At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 55 years inclusive
- ✓Overtly healthy as determined by medical evaluation
- ✓Negative for SARS-CoV-2 on admission
- ✓Able to understand and comply with protocol requirements
- ✕History or presence of clinical condition that could significantly alter drug absorption, metabolism, or elimination
- ✕Clinically significant abnormal blood pressure
- ✕Lymphoma, leukemia, or malignancy within past 5 years (except resected skin carcinomas)
- ✕Breast cancer within past 10 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Oral VH4524184, VH4524184 Formulation A SC, and 8 other interventions for HIV Infections. Currently recruiting, targeting 372 participants across 3 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC).
Participants receive a Formulation B starting dose of VH4524184 LAI subcutaneously (SC).
Participants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM).
Participants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM).
VH4524184 LAI formulations administered SC or IM as single doses that achieve adequate PK exposure targets, may be evaluated for safety and tolerability as multiple doses.
Interventions
VH4524184 to be taken orally.
Low (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.
Starting dose of Placebo Formulation A administered subcutaneously.
Dose of rHuPH20 administered subcutaneously.
Starting dose of VH4524184 LAI Formulation B administered subcutaneously.
Starting dose of Placebo Formulation B administered subcutaneously.
Starting dose VH4524184 LAI Formulation A administered intramuscularly.
Dose of Placebo Formulation A administered intramuscularly.
Starting dose VH4524184 LAI Formulation B administered intramuscularly.
Dose of Placebo Formulation B administered intramuscularly.