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
ViiV Healthcare
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Age 1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Type of Participant and Characteristics 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. 3. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR). 4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and pr…
Interventions
- DrugOral VH4524184
VH4524184 to be taken orally.
- DrugVH4524184 Formulation A SC
VH4524184 LAI Formulation A administered subcutaneously.
- DrugPlacebo Formulation A SC
Placebo Formulation A administered subcutaneously.
- DrugrHuPH20
rHuPH20 administered subcutaneously.
- DrugVH4524184 Formulation B SC
VH4524184 LAI Formulation B administered subcutaneously.
- DrugPlacebo Formulation B SC
Placebo Formulation B administered subcutaneously.
- DrugVH4524184 Formulation A IM
Locations (3)
- GSK Investigational SiteLenexa, Kansas
- GSK Investigational SiteSan Antonio, Texas
- GSK Investigational SiteSalt Lake City, Utah