Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | April 2004 |
| End Date: | December 2006 |
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
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.
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.
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.
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.
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
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