Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CytoDyn, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; HIV Antibodies; Leronlimab; PRO-140 monoclonal antibody

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