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NCT02018510 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117
A Phase 1 study of Healthy and HIV, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 4
- Study locations
NCT02018510 is a Phase 1 study of Healthy and HIV that has completed, run by Rockefeller University. The registered enrollment target is 49 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT02018510, a Phase 1 study of Healthy and HIV, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 4
- Study locations
Study 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.
Interventions
- BIOLOGICAL 1 mg/kg, single dose IV administration of 3BNC117
- BIOLOGICAL 3 mg/kg, single dose IV administration of 3BNC117
- BIOLOGICAL 10 mg/kg, single dose IV administration of 3BNC117
- BIOLOGICAL 30 mg/kg, single dose IV administration of 3BNC117
- BIOLOGICAL 10 mg/kg, two doses IV of 3BNC117
Study Locations (4)
New York
- The Rockefeller University - New York
- Weill Cornell Medical Center - New York
Massachusetts
- Brigham and Women's Hospital - Boston
Other
- University of Cologne - Cologne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02018510
The ClinicalTrials.gov registry entry for NCT02018510 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which 1 mg/kg, single dose IV administration of 3BNC117 is the first listed.
NCT02018510 reports 4 study locations spanning 3 distinct geographic areas - top geographies include New York, Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT02018510 about?
NCT02018510 is a clinical study titled "A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117". 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.
What is the current status of trial NCT02018510?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2014-01. Estimated completion is 2016-01.
What conditions does trial NCT02018510 study?
This clinical trial studies the following conditions: Healthy, HIV.
What interventions are being tested in trial NCT02018510?
The interventions under investigation include: 1 mg/kg, single dose IV administration of 3BNC117 (BIOLOGICAL), 3 mg/kg, single dose IV administration of 3BNC117 (BIOLOGICAL), 10 mg/kg, single dose IV administration of 3BNC117 (BIOLOGICAL), 30 mg/kg, single dose IV administration of 3BNC117 (BIOLOGICAL), 10 mg/kg, two doses IV of 3BNC117 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02018510?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02018510 being conducted?
This trial has 4 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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