Clinical Trial

HIV Antibodies

Study Description

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

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 A?g/ml for at least 3 months in HIV-uninfected participants.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04173819

ParticipAid ID

bmZvpd