Last updated on March 2019

3BNC117-LS First-in-Human Phase 1 Study


Brief description of study

This study is a phase 1, open label, dose-escalation study of the mAb 3BNC117-LS administered intravenously in HIV (human immunodeficiency virus)-uninfected individuals and HIV-infected individuals. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of a single infusion of 3BNC117-LS in HIV-uninfected and HIV-infected individuals.

Detailed Study Description

The proposed study is a Phase 1, open label, dose escalation cohort study of 3BNC117-LS administered intravenously in HIV-uninfected and HIV-1 infected participants.

Study participants will be administered a single intravenous infusion of 3BNC117-LS at one of three increasing dose levels (3 mg/kg, 10 mg/kg and 30 mg/kg) and will be followed for 48 weeks after 3BNC117-LS administration.

This trial will enroll 15 to 30 participants into 5 study groups.

First, eligible participants will be enrolled in Group 1A (n=3-6; HIV-uninfected, 3 mg/kg) and participants will be administered 3BNC117-LS at least one day apart. No more than 2 participants in Group 1A will be administered 3BNC117-LS in a given week.

Enrollment in Group 1B (n=3-6; HIV-uninfected, 10 mg/kg) and Group 2B (n=3-6; HIV-infected on or off ART (antiretroviral therapy), 10 mg/kg) will begin after participants enrolled in Group 1A reach day 42 with 1 dose limiting toxicity (DLT: any adverse event of grade 3 or greater toxicity, if the study investigators recognize a probable or definite attribution to 3BNC117-LS). Participants will be administered 3BNC117-LS at least one day apart.

Enrollment in Group 1C (n=3-6; HIV-uninfected, 30 mg/kg) will begin after participants enrolled in Group 1B reach day 42 with 1 DLT. The first 3 participants enrolled in Group 1C will be administered 3BNC117-LS at least one day apart, and no more than 2 participants will be administered 3BNC117-LS in a given week. After the first 3 participants enrolled in Group 1C reach day 42 with 1 DLT, the remaining 3 participants will be enrolled, and administered 3BNC117-LS at least one day apart.

Enrollment in Group 2C (n=3-6; HIV-infected on or off ART, 30 mg/kg) will begin after participants enrolled in Group 2B reach day 42 with 1 DLT. The first 3 participants enrolled in Group 2C will be administered 3BNC117-LS at least one day apart. After the first 3 participants enrolled in Group 2C reach day 42 with 1 DLT, the remaining 3 participants will be enrolled, and administered 3BNC117-LS at least one day apart.

Following 3BNC117-LS infusion, study participants will return for safety assessments at weeks 1, 2 and 4 following infusion, then bi-monthly or monthly until the end of study follow up.

Serum samples for PK (pharmacokinetic) measurements will be collected before 3BNC117-LS infusion, at the end of the infusion, and at multiple time points during study follow up.

Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117-LS infusion (screen, pre-infusion and day 0) and at all follow up visits in Groups 2B and 2C.

All participants will be followed for 48 weeks after 3BNC117-LS infusion.

Clinical Study Identifier: NCT03254277

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