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Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

Sponsor
CytoDyn, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00110591
Collaborator
(none)
20
Enrollment
1
Location
5
Arms
32
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PRO 140
 Phase 1

Detailed Description

PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.

Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I, Randomized, Double Blind, Placebo Controlled, Single-Dose, Rising Dose Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO 140 in Healthy Volunteers
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Intravenous placebo for PRO 140

Drug: PRO 140
Monoclonal antibody to CCR5
Other Names:
  • Humanized monoclonal antibody to CCR5

    		•
    Experimental: PRO 140 dose 1

    0.1 mg/kg PRO 140 by intravenous infusion

    Drug: PRO 140
    Monoclonal antibody to CCR5
    Other Names:
  • Humanized monoclonal antibody to CCR5

    		•
    Experimental: PRO 140 dose 2

    0.5 mg/kg PRO 140 by intravenous infusion

    Drug: PRO 140
    Monoclonal antibody to CCR5
    Other Names:
  • Humanized monoclonal antibody to CCR5

    		•
    Experimental: PRO 140 dose 3

    2.0 mg/kg PRO 140 by intravenous infusion

    Drug: PRO 140
    Monoclonal antibody to CCR5
    Other Names:
  • Humanized monoclonal antibody to CCR5

    		•
    Experimental: PRO 140 dose 4

    5.0 mg/kg PRO 140 by intravenous infusion

    Drug: PRO 140
    Monoclonal antibody to CCR5
    Other Names:
  • Humanized monoclonal antibody to CCR5

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of PRO 140 [60 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Not more than 20% below or 20% above ideal weight for height and estimated frame size

    • Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

    Exclusion Criteria:

    • History of clinically significant disease

    • History of clinically significant allergies, including drug allergy

    • Participated in another clinical trial within the 3 months prior to study entry

    • HIV infected

    • Hepatitis B or C virus infected

    • Active significant infection

    • Prior exposure, allergy, or known hypersensitivity to PRO 140

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MDS Pharma Services Lincoln Nebraska United States 68502

    Sponsors and Collaborators

    • CytoDyn, Inc.

    Investigators

    • Study Chair: William Olson, PhD, Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CytoDyn, Inc.
    ClinicalTrials.gov Identifier:
    NCT00110591
    Other Study ID Numbers:
    • 5R44AI046871-04
    • PRO140-1101
    First Posted:
    May 11, 2005
    Last Update Posted:
    Dec 15, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    HIV Infections
    Leronlimab

    Study Results

    No Results Posted as of Dec 15, 2015