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First received: March 16, 2023

Clinical Trial: A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Volunteers

Study Type: INTERVENTIONAL


Official Title: Single-center, Randomized, Double-blind, Placebo-controlled, Ascending-Dose Study to Evaluate the Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin (Rhu-pGSN) After Intravenous Administ

Brief Summary: Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight.Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects).Subjects will be healthy adult volunteers 18-55 years of age.

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