Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

NCT ID: NCT00110591

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-16
• Study Completion Date: 2008-03-31

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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Intravenous placebo for PRO 140

Group Type: PLACEBO_COMPARATOR

PRO 140

Intervention Type: DRUG

Monoclonal antibody to CCR5

PRO 140 dose 1

0.1 mg/kg PRO 140 by intravenous infusion

Group Type: EXPERIMENTAL

PRO 140

Intervention Type: DRUG

Monoclonal antibody to CCR5

PRO 140 dose 2

0.5 mg/kg PRO 140 by intravenous infusion

Group Type: EXPERIMENTAL

PRO 140

Intervention Type: DRUG

Monoclonal antibody to CCR5

PRO 140 dose 3

2.0 mg/kg PRO 140 by intravenous infusion

Group Type: EXPERIMENTAL

PRO 140

Intervention Type: DRUG

Monoclonal antibody to CCR5

PRO 140 dose 4

5.0 mg/kg PRO 140 by intravenous infusion

Group Type: EXPERIMENTAL

PRO 140

Intervention Type: DRUG

Monoclonal antibody to CCR5

Interventions

PRO 140

Monoclonal antibody to CCR5

Intervention Type: DRUG

Other Intervention Names

Humanized monoclonal antibody to CCR5

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CytoDyn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Olson, PhD

Role: STUDY_CHAIR

Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.

Locations

MDS Pharma Services

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

PRO140-1101

Identifier Type: OTHER

Identifier Source: secondary_id

5R44AI046871-04

Identifier Type: NIH

Identifier Source: org_study_id

View Link