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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: Completed Phase 1 study of Healthy and HIV, sponsored by Rockefeller University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To evaluate the safety and tolerability profile of one or two intravenous infusions of 3BNC117 at 3 increasing dose levels in HIV-infected and HIV-uninfected individuals.

Conditions Studied

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

FieldValue
Enrollment Target 49 participants
Start Date 2014-01
Est. Completion 2016-01
Phase Phase 1
Rockefeller University

117 total trials

What the finished NCT02018510 record still lists

NCT02018510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02018510's enrollment target sits among peer trials

49 474th of 1090 higher than 613 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02018510, the US trial registry maintained by the National Library of Medicine. NCT02018510 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.