A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074
NCT02511990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2018-02-05
Summary
This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.
Conditions
- Healthy
- HIV
Interventions
- BIOLOGICAL
-
3 mg/kg, single dose IV administration of 10-1074
3 mg/kg, single dose IV administration of 10-1074
- BIOLOGICAL
-
10 mg/kg, single dose IV administration of 10-1074
10 mg/kg, single dose IV administration of 10-1074
- BIOLOGICAL
-
30 mg/kg, single dose IV administration of 10-1074
30 mg/kg, single dose IV administration of 10-1074
Sponsors & Collaborators
-
University of Cologne
collaborator OTHER -
Rockefeller University
lead OTHER
Principal Investigators
-
Marina Caskey, MD · Rockefeller University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2016-12-31
- Completion
- 2017-12-31
Countries
- United States
- Germany
Study Locations
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