NCT04173819

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-01-25
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2019-11-22
• Last updated: 2025-05-06

Locations

9 sites across 5 countries: United States, Kenya, Rwanda, South Africa, Uganda

Regulatory

• FDA-regulated drug study