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

No results posted yet for this study

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

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

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 NCT02511990 on ClinicalTrials.gov