CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
CPT31 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04672083
NCT04672083Phase 1Completed
CompareCT.gov

A Phase Ia Clinical Study of HIV Entry Inhibitor CPT31: Single Ascending Dose Study of Safety, Tolerability, Immunogenicity, and Pharmacokinetics in Healthy Adults

Navigen, Inc.·interventional·Posted Dec 17, 2020·Updated Feb 21, 2023

In Brief

A Phase 1 clinical trial evaluating CPT31 and Placebo for HIV Infections. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsCovance, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartNov 16, 2020
Primary CompletionApr 26, 2021
Study CompletionApr 29, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.5 years ago

Interventions

CPT31drug

CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer

Placebodrug

matching placebo