NCT03762031

A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GC4711 30mg	single dose given via a 15 minute intravenous infusion
DRUG	GC4711 60mg	single dose given via a 15 minute intravenous infusion
DRUG	GC4711 90mg	single dose given via a 15 minute intravenous infusion
DRUG	GC4711 120mg	single dose given via a 15 minute intravenous infusion
DRUG	Placebo	single dose of normal saline given via a 15 minute intravenous infusion
DRUG	GC4711 75mg	single dose given via a 15 minute intravenous infusion
DRUG	GC4711 105mg	single dose given via a 15 minute intravenous infusion

Timeline

• Start date: 2019-03-19
• Primary completion: 2020-03-04
• Completion: 2020-03-04
• First posted: 2018-12-03
• Last updated: 2020-08-14

Locations

1 site across 1 country: Australia