A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
NCT06724640 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2025-10-29
Summary
The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.
Conditions
- HIV Infections
Interventions
- DRUG
-
VH4011499 low dose Injection
VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
- DRUG
-
VH4011499 high dose Injection
VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
- DRUG
-
Placebo Injection will be administered either subcutaneously or intramuscularly.
Sponsors & Collaborators
-
ViiV Healthcare
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-16
- Primary Completion
- 2028-08-16
- Completion
- 2028-08-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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