NCT03194139

A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Crossover, Single Dose Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study will be a double-blind, randomized, crossover, single-dose assessment of IV-administered GC4711 compared to GC4419 in healthy volunteers. Consenting subjects will undergo screening procedures within 28 days of the start of dosing. Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine from all subjects. Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety review by the Galera study team , if no safety concerns are identified after the last subject completes study participation, enrollment will continue in 2 stages to a crossover study design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are identified in stage 1 following a clinical safety review by the Galera study team, 20 subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) -\> Ref (GC4419) or Ref (GC4419) -\> Test (GC4711). On Day 1, subjects will receive the first treatment they were randomized to, and on Day 4 (following a washout), they will receive the second treatment. Subjects will be followed up for 2 days after the second treatment.

Conditions

• Healthy Volunteers
• Healthy

Interventions

Type	Name	Description
DRUG	GC4711 30 mg IV	GC4711 will be infused IV as a single dose of 30 mg (3 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump
DRUG	GC4711 50 mg IV	GC4711 will be infused IV as a single dose of 50 mg (5 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totalling 250 mL, over a 60-minute period using a programmable pump.
DRUG	GC4419 45 mg IV	GC4419 will be infused IV as a single dose of 45 mg (5 mL GC4419 at 9 mg/mL) in 245 mL normal (0.9%) saline, totalling 250 mL, over a 60-minute period using a programmable pump.

Timeline

• Start date: 2017-09-25
• Primary completion: 2017-12-24
• Completion: 2017-12-24
• First posted: 2017-06-21
• Last updated: 2018-02-14

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study