NCT05184452

A 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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) are conducting this study to test a combination of different antibodies against HIV. HIV is the virus that causes AIDS. Antibodies are made by the body as one way to respond to or fight infection. Researchers can also make antibodies in laboratories and give them to people by infusions into a vein or under the skin. There are 2 parts of this study, Part A and Part B. About 15 people will take part in Part A of this study to test one study antibody. After early safety results from Part A are obtained, a decision will be made as to whether or not to do Part B of the study. Part B of the study would test a combination of 3 antibodies. If it is decided to move forward with Part B, 80 more people will join.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	PGDM1400LS (5mg/kg, IV)	5 mg/kg to be administered via IV infusion
DRUG	PGDM1400LS (20mg/kg, IV)	20 mg/kg to be administered via IV infusion
DRUG	PGDM1400LS (20mg/kg, SC)	20 mg/kg to be administered via SC infusion
DRUG	PGDM1400LS (40mg/kg, IV)	40 mg/kg to be administered via IV infusion
DRUG	PGDM1400LS (40mg/kg, SC)	40 mg/kg to be administered via SC infusion
DRUG	PGDM1400LS (1.4g, IV)	1.4gram to be administered via IV infusion
DRUG	PGDM1400LS (1.4g, SC)	1.4gram to be administered via SC infusion
DRUG	VRC07-523LS (20mg/kg, IV)	VRC07-523LS 20mg/kg administered via IV infusion
DRUG	VRC07-523LS (20mg/kg, SC)	VRC07-523LS 20mg/kg administered via SC infusion
DRUG	VRC07-523LS (1.4g, IV)	VRC07-523LS 1.4g administered via IV infusion
DRUG	VRC07-523LS (1.4g, SC)	VRC07-523LS 1.4g administered via SC infusion
DRUG	VRC07-523LS (40mg/kg, IV)	VRC07-523LS 40mg/kg administered via IV infusion
DRUG	PGT121.414.LS (20mg/kg, IV)	PGT121.414.LS 20mg/kg administered via IV infusion
DRUG	PGT121.414.LS (20mg/kg, SC)	PGT121.414.LS 20mg/kg administered via SC infusion
DRUG	PGT121.414.LS (1.4g, IV)	PGT121.414.LS 1.4g administered via IV infusion
DRUG	PGT121.414.LS (1.4g, SC)	PGT121.414.LS 1.4g administered via SC infusion
DRUG	PGT121.414.LS (40mg/kg, IV)	PGT121.414.LS 40mg/kg administered via IV infusion

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-07-19
• Completion: 2023-07-19
• First posted: 2022-01-11
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

13 sites across 4 countries: United States, Kenya, South Africa, Zimbabwe

Regulatory

• FDA-regulated drug study