Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110591
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2005-05-10
Brief Title:
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRO140-1101 | OTHER | CytoDyn | None |