A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV
ViiV Healthcare
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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. * Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies: * Is a Participant of Nonchildbearing potential (PONCBP) * Is a Participant of Childbearing potential (POCBP) and using a highly effective method…
Interventions
- DrugVH4011499 low dose Injection
VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.
- DrugVH4011499 high dose Injection
VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.
- DrugPlacebo
Placebo Injection will be administered either subcutaneously or intramuscularly.
Locations (2)
- GSK Investigational SiteLas Vegas, Nevada
- GSK Investigational SiteAustin, Texas