Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517855
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2007-08-15
Brief Title:
Phase 1 Study Evaluating the Safety Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers
Sponsor:
Protalex Inc
Organization:
Protalex Inc
Study Overview
Official Title:
A Phase 1 Double-Blind Randomized Placebo-Controlled Single-Dose Escalation Study of the Safety and Pharmacokinetics of Intravenous Doses of PRTX-100 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2008-05
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:
This study is the second human clinical study with PRTX-100 It is designed to assess the safety of a single intravenous IV dose of PRTX-100 as well as how the drug is eliminated from the blood after dosing Additionally this study provides an opportunity to monitor immune system response to PRTX-100
Detailed Description:
A total of 20 healthy subjects will be enrolled into one of two dosing cohorts Each dosing cohort will consist of 10 subjects Within each cohort subjects will be randomized to clinical trial material CTM PRTX-100 or placebo such that 8 subjects receive PRTX-100 and 2 subjects receive placebo The PRTX-100 doses to be assessed in an ascending fashion are 030 mcgkg and 045 mcgkg Dosing of Cohort 2 will occur after the Investigator reviews Day 0-14 safety data and confers with the Sponsor Medical Monitor
Subjects will be confined to the clinical pharmacology research unit for 5 days following dosing Each cohort will have safety pharmacokinetic and pharmacodynamic assessments over the 5-day post-dose period Subjects will also have follow-up assessments at 6 7 10 1 14 1 30 2 and 60 2 days post-dose
Subjects will be confined to the clinical pharmacology research unit for 5 days following dosing Each cohort will have safety pharmacokinetic and pharmacodynamic assessments over the 5-day post-dose period Subjects will also have follow-up assessments at 6 7 10 1 14 1 30 2 and 60 2 days post-dose
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