At a glance
ClinicalIndex Comparison Record- ✓Overtly healthy participants
- ✓Two consecutive negative SARS-CoV-2 PCR tests prior to dosing
- ✓Body weight >50 kg and BMI 19-32 kg/m²
- ✓Capable of giving signed informed consent
- ✕History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders that significantly alter drug absorption/metabolism/elimination or create risk
- ✕Abnormal blood pressure
- ✕Lymphoma, leukemia, or malignancy within past 5 years (except resected basal cell or squamous epithelial skin cancers without 3-year metastatic disease evidence)
- ✕Breast cancer within past 10 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Administered VH4011499 in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating VH4011499, Placebo, and 1 other intervention for HIV Infections. Completed, enrolled 73 participants across 2 sites.
Detailed Summary
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate multiple ascending doses (MAD). Part 3 will investigate single dose of a new formulation of VH4011499. The transition from SAD to MAD will be based on the assessment of the Safety and Dose Escalation Committee.
Study Details
Timeline
Interventions
VH4011499 will be administered.
Placebo will be administered.
Midazolam will be administered