IAVI C100
Status:Ongoing
Phase:I/II
Principal Investigator(s):Marina Caskey
Objective: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 µg/ml for at least 3 months in HIV-uninfected participants.
Last updated September 19, 2022
Prevention Option(s):Antibody Related Research
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Group 1
Single Agent, abdominal subcutaneous injection, 10:2 ratio for Ab:placebo;
Biological: 3BNC117-LS-J
300mg
Biological: Placebo
Buffer Solution
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionExperimental: Group 2
Single agent, abdominal subcutaneous injection 10:2 ratio for Ab:placebo;
Biological: 10-1074-LS-J
300mg
Biological: Placebo
Buffer Solution
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionExperimental: Group 3
Single agent intravenous injection 10:2 ratio for Ab:placebo;
Biological: 3BNC117-LS-J
300mg
Biological: Placebo
0.9% Saline
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionExperimental: Group 4
Single agent intravenous injection 10:2 ratio for Ab:placebo
Biological: 10-1074-LS-J
300mg
Biological: Placebo
0.9% Saline
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionExperimental: Group 5
Combined agent intravenous injection 10:2 ratio for Ab:placebo; Biological: Combination 3BNC117-LS-J and 10-1074-LS-J
30mg/kg of each
Biological: Placebo
0.9% Saline
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionExperimental: Group 6
Subcutaneous injection combined ratio 1 with loading dose 30:3 ratio of Ab:Placebo;
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: Placebo
Buffer Solution
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionExperimental: Group 7
Subcutaneous injection in abdomen combined ratio 2 with loading dose 30:3 ratio of Ab:Placebo
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: Placebo
Buffer Solution
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionExperimental: Group 8
Subcutaneous injection in abdomen combined ratio 3 with loading dose 30:3 ratio of Ab:Placebo
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
Buffer Solution
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionExperimental: Group 9
Subcutaneous injection in abdomen combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
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: Placebo
Buffer Solution
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionExperimental: Group 10
Subcutaneous injection in arm combined ratio 2 without loading dose 30:3 ratio of Ab:Placebo
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: Placebo
Buffer Solutio
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT04173819
Trial Sponsors:
IAVI
Start Date
End Date
January 25, 2019
September 21, 2022
Enrollment:225
Age range:
18 Years ↔
45 Years
Population:Cisgender Men, Cisgender Women