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A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117

NCT02018510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-12-26

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

1 mg/kg, single dose IV administration of 3BNC117

1 mg/kg, single dose IV administration of 3BNC117

BIOLOGICAL

3 mg/kg, single dose IV administration of 3BNC117

3 mg/kg, single dose IV administration of 3BNC117

BIOLOGICAL

10 mg/kg, single dose IV administration of 3BNC117

10 mg/kg, single dose IV administration of 3BNC117

BIOLOGICAL

30 mg/kg, single dose IV administration of 3BNC117

30 mg/kg, single dose IV administration of 3BNC117

BIOLOGICAL

10 mg/kg, two doses IV of 3BNC117

10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12

BIOLOGICAL

30 mg/kg, two doses IV of 3BNC117

30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • University of Cologne

    collaborator OTHER

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Marina Caskey, MD · Rockefeller Univesrity

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
2014-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02018510 on ClinicalTrials.gov