Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

• ClinicalTrials.gov Identifier: NCT00110591
• Recruitment Status: Completed
• First Posted: May 11, 2005
• Last Update Posted: December 15, 2015
• Sponsor: CytoDyn, Inc.
• Information provided by (Responsible Party): CytoDyn, Inc.

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
HIV Infections	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 (Clinical Trial)
• 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: April 2004
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Intravenous placebo for PRO 140	Drug: PRO 140; Monoclonal antibody to CCR5; Other Name: 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 Name: 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 Name: 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 Name: 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 Name: Humanized monoclonal antibody to CCR5

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

United States, Nebraska

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.

More Information

• Responsible Party: CytoDyn, Inc.
• ClinicalTrials.gov Identifier: NCT00110591
• Other Study ID Numbers: 5R44AI046871-04 ( U.S. NIH Grant/Contract ); PRO140-1101 ( Other Identifier: CytoDyn )
• First Posted: May 11, 2005
• Last Update Posted: December 15, 2015
• Last Verified: December 2015

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Leronlimab; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents