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NOT YET RECRUITING
NCT07822477
PHASE1

A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

Summary

The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV). This study will be conducted following the availability of initial safety and PK clinical data from formulation of the parent drug VH4524184.

Official title: A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Randomized, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Parenterally Administered VH5356136 in Adult Participants Without HIV

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-11-06

Completion Date

2029-05-09

Last Updated

2026-09-16

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

VH5356136 Formulation 1

Participants will receive VH5356136 Formulation 1 on Day 1.

DRUG

VH5356136 Formulation 2

Participants will receive VH5356136 Formulation 2 on Day 1.

DRUG

Placebo for VH5356136 Formulation 1

Participants will receive placebo for VH5356136 Formulation 1 on Day 1.

DRUG

Placebo for VH5356136 Formulation 2

Participants will receive placebo for VH5356136 Formulation 2 on Day 1.