NCT06724640 A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
| NCT ID | NCT06724640 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ViiV Healthcare |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2028-08-16 |
Trial Parameters
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Brief 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 Criteria
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 of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy. * Capable of giving signed informed consent. Exclusion Criteria: * History or presence of cardiovascular, respirato
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