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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

January 25, 2019

Primary Completion Date

September 1, 2023

Study Completion Date

September 1, 2023

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

Trial Locations (9)

10065

The Rockefeller University, New York

98109

Fred Hutchinson Cancer Research Center, Seattle

02115

Brigham and Women's Hospital, Boston

Unknown

Partners in Health Research and Development, Thika

Kenya AIDS Vaccine Initiative - Institute of Clinical Research, Nairobi

Center for Family Health Research, Kigali

Wits Reproductive Health and HIV Institute, Johannesburg

Uganda Virus Research Institute, Entebbe

Infectious Diseases Institute Kasangati, Kampala

All Listed Sponsors
collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

Rockefeller University

OTHER

collaborator

Brigham and Women's Hospital

OTHER

lead

International AIDS Vaccine Initiative

NETWORK

NCT04173819 - Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults | Biotech Hunter | Biotech Hunter