Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
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
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
Started Apr 2004
Longer than P75 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2004
CompletedFirst Submitted
Initial submission to the registry
May 10, 2005
CompletedFirst Posted
Study publicly available on registry
May 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2008
CompletedResults Posted
Study results publicly available
March 14, 2023
CompletedMarch 14, 2023
February 1, 2023
1.6 years
May 10, 2005
February 15, 2023
February 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of PRO 140
60 days
Study Arms (5)
Placebo
PLACEBO COMPARATORIntravenous placebo for PRO 140
PRO 140 dose 1
EXPERIMENTAL0.1 mg/kg PRO 140 by intravenous infusion
PRO 140 dose 2
EXPERIMENTAL0.5 mg/kg PRO 140 by intravenous infusion
PRO 140 dose 3
EXPERIMENTAL2.0 mg/kg PRO 140 by intravenous infusion
PRO 140 dose 4
EXPERIMENTAL5.0 mg/kg PRO 140 by intravenous infusion
Interventions
Monoclonal antibody to CCR5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CytoDyn, Inc.lead
Study Sites (1)
MDS Pharma Services
Lincoln, Nebraska, 68502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joe Meidling
- Organization
- CytoDyn, Inc.
Study Officials
- STUDY CHAIR
William Olson, PhD
Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2005
First Posted
May 11, 2005
Study Start
April 16, 2004
Primary Completion
November 7, 2005
Study Completion
March 31, 2008
Last Updated
March 14, 2023
Results First Posted
March 14, 2023
Record last verified: 2023-02