First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS
NCT03554408 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77
Last updated 2021-08-04
Summary
This first clinical study of 10-1074-LS will evaluate its safety, tolerability and pharmacokinetics profile when administered alone or in combination with 3BNC117-LS to HIV (human immunodeficiency virus) -infected and HIV-uninfected individuals.
Conditions
- Human Immunodeficiency Virus
Interventions
- DRUG
-
10-1074-LS
Subcutaneous injection of 10-1074-LS
- DRUG
-
10-1074-LS
Intravenous infusion of 10-1074-LS
- DRUG
-
3BNC117-LS
Subcutaneous injection of 3BNC117-LS
- DRUG
-
3BNC117-LS
Intravenous infusion of 3BNC117-LS
Sponsors & Collaborators
-
Rockefeller University
lead OTHER
Principal Investigators
-
Marina Caskey, MD · The Rockefeller University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-06-20
- Primary Completion
- 2021-02-04
- Completion
- 2021-02-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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