NCT02018510

A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117

A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117 Monoclonal Antibody in HIV-infected and HIV-uninfected Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects.

Detailed description

In preclinical studies carried out in humanized mice and non-human primates, 3BNC117 alone or in combination with other neutralizing antibodies led to protection from HIV-1 or SHIV infection and also to sustained suppression of HIV-1 plasma viremia. The aims of this protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 3BNC117 in both HIV-infected and HIV-uninfected subjects,and its antiretroviral activity in HIV-infected subjects.

Conditions

• Healthy
• HIV

Interventions

Type	Name	Description
BIOLOGICAL	1 mg/kg, single dose IV administration of 3BNC117	1 mg/kg, single dose IV administration of 3BNC117
BIOLOGICAL	3 mg/kg, single dose IV administration of 3BNC117	3 mg/kg, single dose IV administration of 3BNC117
BIOLOGICAL	10 mg/kg, single dose IV administration of 3BNC117	10 mg/kg, single dose IV administration of 3BNC117
BIOLOGICAL	30 mg/kg, single dose IV administration of 3BNC117	30 mg/kg, single dose IV administration of 3BNC117
BIOLOGICAL	10 mg/kg, two doses IV of 3BNC117	10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
BIOLOGICAL	30 mg/kg, two doses IV of 3BNC117	30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-12-23
• Last updated: 2016-12-26

Locations

4 sites across 2 countries: United States, Germany