HIV Antibodies
common.study.values.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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
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
participant.views.study.view.additional
participant.views.study.view.scientific-title
Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults
common.study.values.clinical-trial-id
NCT04173819
participant.views.study.view.id
bmZvpd
