NCT00517855

Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Protalex, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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: 0.30 mcg/kg and 0.45 mcg/kg. 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	PRTX-100 (Staphylococcal protein A)

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-08-17
• Last updated: 2008-05-06

Locations

1 site across 1 country: United States