Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: PRO 140 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- Safety and tolerability of PRO 140
- pharmacokinetics and pharmacodynamics of PRO 140
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Nebraska | |
| MDS Pharma Services | |
| Lincoln, Nebraska, United States, 68502 | |
| Study Chair: | William Olson, PhD | Vice President, Clinical Research, Progenics Pharmaceuticals, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00110591 History of Changes |
| Other Study ID Numbers: | 5R44-AI046871-04, PRO140-1101 |
| Study First Received: | May 10, 2005 |
| Last Updated: | September 17, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013