Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers

CytoDyn

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: PRO 140

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110591

PRO140-1101 (Other Identifier)

5R44AI046871-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intravenous placebo for PRO 140

Treatment:

Drug: PRO 140

PRO 140 dose 1

Experimental group

Description:

0.1 mg/kg PRO 140 by intravenous infusion

Treatment:

Drug: PRO 140

PRO 140 dose 2

Experimental group

Description:

0.5 mg/kg PRO 140 by intravenous infusion

Treatment:

Drug: PRO 140

PRO 140 dose 3

Experimental group

Description:

2.0 mg/kg PRO 140 by intravenous infusion

Treatment:

Drug: PRO 140

PRO 140 dose 4

Experimental group

Description:

5.0 mg/kg PRO 140 by intravenous infusion

Treatment:

Drug: PRO 140