Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults

Summary

This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels \>10 µg/ml for at least 3 months in HIV-uninfected participants.

Conditions

• HIV-1-infection

Interventions

BIOLOGICAL

3BNC117-LS-J

300mg

BIOLOGICAL

10-1074-LS-J

300mg

BIOLOGICAL

Combination 3BNC117-LS-J and 10-1074-LS-J

30mg/kg of each

BIOLOGICAL

Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1

Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2

BIOLOGICAL

Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2

Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2

BIOLOGICAL

Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3

Total \~300 mg (\< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2

BIOLOGICAL

Placebo

0.9% Saline

BIOLOGICAL

Placebo

Buffer Solution

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Rockefeller University

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• International AIDS Vaccine Initiative

  lead NETWORK

Principal Investigators

• Marina Caskey, MD · Rockefeller University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-25

Primary Completion

2023-09-01

Completion

2023-09-01

FDA Drug

Yes

Countries

• United States
• Kenya
• Rwanda
• South Africa
• Uganda

Study Locations