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

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.

Conditions

• HIV Infections

Interventions

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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Department of Health and Human Services

  collaborator FED

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Colleen Kelley · Emory University

• Marc Siegel · George Washington University

• Sharana Mahomed · Centre for the AIDS Programme of Research in South Africa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2023-07-19

Completion

2023-07-19

FDA Drug

Yes

Countries

• United States
• Kenya
• South Africa
• Zimbabwe

Study Locations