MedTrace Logo

Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers

NCT01292174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-12-18

No results posted yet for this study

Summary

The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three dose levels. Drug administration begins at the lowest dose. After 4 of 8 volunteers in the first group have received all study drug injections and have completed 6 additional weeks of follow-up, an independent safety monitoring group will review available data before approving initiation of the next higher dose-group. This process will be repeated prior to initiation of the 3rd and highest dose-group.

All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each to test drug levels.

Conditions

  • Prevention of Infection With HIV-1

Interventions

BIOLOGICAL

ibalizumab (biologic/MAb) for SC Injection or placebo

ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg

BIOLOGICAL

ibalizumab (biologic/MAb) for SC Injection or placebo

ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg

BIOLOGICAL

ibalizumab (biologic/MAb) for SC Injection or placebo

ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg

Sponsors & Collaborators

  • Aaron Diamond AIDS Research Center

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • TaiMed Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Stanley T Lewis, MD, MPH · TaiMed Biologics, USA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01292174 on ClinicalTrials.gov