Healthy Volunteers Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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