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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 25, 2017

Primary Completion Date

December 24, 2017

Study Completion Date

December 24, 2017

Conditions
Healthy VolunteersHealthy
Interventions
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.

Trial Locations (1)

3004

Nucleus Network Limited, Melbourne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Galera Therapeutics, Inc.

INDUSTRY

NCT03194139 - A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers | Biotech Hunter | Biotech Hunter