drugset / Trial / NCT04672083
A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
Phase 1
Completed
32 enrolled
Navigen, Inc.
Covance · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of the HIV entry inhibitor CPT31 (cholesterol-PIE12-2-trimer) in healthy adults. This is a randomized, placebo-controlled, double-blind, single ascending dose study.
Timeline
- Start
- 2020-11-16
- Primary completion
- 2021-04-26
- Completion
- 2021-04-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPT31 | Peptide | 0.01 mg/kg | Subcutaneous |
| Subject | CPT31 | Peptide | 0.04 mg/kg | Subcutaneous |
| Subject | CPT31 | Peptide | 0.12 mg/kg | Subcutaneous |
| Subject | CPT31 | Peptide | 0.24 mg/kg | Subcutaneous |