Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110591
• Other study ID #: 5R44AI046871-04
• Secondary ID: PRO140-1101
• Status: Completed
• Phase: Phase 1
• Start date: April 16, 2004
• Est. completion date: March 31, 2008

Study information

• Verified date: February 2023
• Source: CytoDyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2008
• Est. primary completion date: November 7, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• PRO 140
Monoclonal antibody to CCR5

Locations

Country	Name	City	State
United States	MDS Pharma Services	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
CytoDyn, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of PRO 140		60 days