CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 95 enrolled
Drug / intervention
PGDM1400LS (5mg/kg, IV) +16 moredrug
Likely dose
PGDM1400LS (5mg/kg, IV)from 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/NCT05184452
NCT05184452Phase 1Completed
CompareCT.gov

A Phase 1 Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 11, 2022·Updated Feb 10, 2025

In Brief

A Phase 1 clinical trial evaluating PGDM1400LS (5mg/kg, IV), PGDM1400LS (20mg/kg, IV), and 15 other interventions for HIV Infections. Completed, enrolled 95 participants across 13 sites in 4 countries.

Detailed Summary

Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesKenya, South Africa, United States, Zimbabwe
CollaboratorsNational Institutes of Health (NIH), Department of Health and Human Services

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJan 11, 2022
Enrollment StartNov 15, 2021
Primary CompletionJul 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.5 years ago

Interventions

PGDM1400LS (5mg/kg, IV)drug

5 mg/kg to be administered via IV infusion

PGDM1400LS (20mg/kg, IV)drug

20 mg/kg to be administered via IV infusion

PGDM1400LS (20mg/kg, SC)drug

20 mg/kg to be administered via SC infusion

PGDM1400LS (40mg/kg, IV)drug

40 mg/kg to be administered via IV infusion

PGDM1400LS (40mg/kg, SC)drug

40 mg/kg to be administered via SC infusion

PGDM1400LS (1.4g, IV)drug

1.4gram to be administered via IV infusion

PGDM1400LS (1.4g, SC)drug

1.4gram to be administered via SC infusion

VRC07-523LS (20mg/kg, IV)drug

VRC07-523LS 20mg/kg administered via IV infusion

VRC07-523LS (20mg/kg, SC)drug

VRC07-523LS 20mg/kg administered via SC infusion

VRC07-523LS (1.4g, IV)drug

VRC07-523LS 1.4g administered via IV infusion

VRC07-523LS (1.4g, SC)drug

VRC07-523LS 1.4g administered via SC infusion

VRC07-523LS (40mg/kg, IV)drug

VRC07-523LS 40mg/kg administered via IV infusion

PGT121.414.LS (20mg/kg, IV)drug

PGT121.414.LS 20mg/kg administered via IV infusion

PGT121.414.LS (20mg/kg, SC)drug

PGT121.414.LS 20mg/kg administered via SC infusion

PGT121.414.LS (1.4g, IV)drug

PGT121.414.LS 1.4g administered via IV infusion

PGT121.414.LS (1.4g, SC)drug

PGT121.414.LS 1.4g administered via SC infusion

PGT121.414.LS (40mg/kg, IV)drug

PGT121.414.LS 40mg/kg administered via IV infusion