drugset
drugset / Trial / NCT05789745

A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

NCT05789745 ↗

Phase 1 Completed 32 enrolled BioAegis Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-03-14
Primary completion
2023-05-24
Completion
2023-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Rhu-pGSN Protein / enzyme biologic 6 mg/kg Intravenous
Subject Rhu-pGSN Protein / enzyme biologic 12 mg/kg Intravenous
Subject Rhu-pGSN Protein / enzyme biologic 18 mg/kg Intravenous
Subject Rhu-pGSN Protein / enzyme biologic 24 mg/kg Intravenous

Indications

No indication recorded.