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Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

NCT00110591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-14

Study results available
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Summary

The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.

Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

Conditions

  • HIV Infections

Interventions

DRUG

PRO 140

Monoclonal antibody to CCR5

Sponsors & Collaborators

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • William Olson, PhD · Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-16
Primary Completion
2005-11-07
Completion
2008-03-31

Countries

  • United States

Study Locations

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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 NCT00110591 on ClinicalTrials.gov