Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT00110591
First received: May 10, 2005
Last updated: July 9, 2013
Last verified: July 2013

May 10, 2005
July 9, 2013
April 2004
December 2006   (final data collection date for primary outcome measure)
Safety and tolerability of PRO 140 [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of PRO 140
  • pharmacokinetics and pharmacodynamics of PRO 140
Complete list of historical versions of study NCT00110591 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
Drug: PRO 140
Monoclonal antibody to CCR5
  • Placebo Comparator: Placebo
    Intravenous placebo for PRO 140
  • Experimental: PRO 140 dose 1
    0.1 mg/kg PRO 140 by intravenous infusion
    Intervention: Drug: PRO 140
  • Experimental: PRO 140 dose 2
    0.5 mg/kg PRO 140 by intravenous infusion
    Intervention: Drug: PRO 140
  • Experimental: PRO 140 dose 3
    2.0 mg/kg PRO 140 by intravenous infusion
    Intervention: Drug: PRO 140
  • Experimental: PRO 140 dose 4
    5.0 mg/kg PRO 140 by intravenous infusion
    Intervention: Drug: PRO 140
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110591
5R44-AI046871-04, PRO140-1101
No
CytoDyn, Inc.
CytoDyn, Inc.
Not Provided
Study Chair: William Olson, PhD Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
CytoDyn, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP