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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: PRO 140

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability of PRO 140	60 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 16, 2004
• Primary Completion (Actual): November 7, 2005
• Study Completion (Actual): March 31, 2008

Study Registration Dates

• First Submitted: May 10, 2005
• First Submitted That Met QC Criteria: May 10, 2005
• First Posted (Estimate): May 11, 2005

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Leronlimab
• Other Study ID Numbers: 5R44AI046871-04 (U.S. NIH Grant/Contract); PRO140-1101 (Other Identifier: CytoDyn)