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

Galera Therapeutics, Inc.1 site in 1 country70 target enrollmentMarch 19, 2019

ConditionsHealthy

InterventionsGC4711 75mg GC4711 30mg GC4711 60mg GC4711 90mg GC4711 120mg Placebo GC4711 105mg

DrugsGC4711 30mg GC4711 60mg GC4711 90mg GC4711 120mg Placebo GC4711 75mg GC4711 105mg

Overview

Phase: Phase 1
Intervention: GC4711 75mg
Conditions: Healthy
Sponsor: Galera Therapeutics, Inc.
Enrollment: 70
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 19, 2019

End Date

March 4, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Galera Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy men and women between 18 and 50 years
•Subjects who provide written informed consent
•Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
•Subjects in general good health
•Blood pressure and pulse within normal limits
•Male subjects must practice effective contraception
•Female subjects must:
•Have a negative serum pregnancy test during
•Be non-lactating;
•Be at least 2 years postmenopausal, surgically sterile, or practicing effective contraception.

Exclusion Criteria

•History of clinically significant illness or medical history which would preclude them from the study.
•Known contraindication, hypersensitivity and/or allergy to study drugs
•Use of any prescription or over-the-counter medication within one week prior to study drug administration
•Anticipated need for any medication during the study
•Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors
•Use of other drugs that may, in the judgment of the Investigator, create a risk for a precipitous decrease in blood pressure
•Presence of orthostatic hypotension at screening
•Use of any vitamin or mineral supplement 24 hours before dosing or throughout study
•Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
•Known history of substance abuse, drug addiction, or alcoholism within 3 years