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

Sponsor

Galera Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03762031

Collaborator

(none)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GC4711 30mg Drug: GC4711 60mg Drug: GC4711 90mg Drug: GC4711 120mg Drug: Placebo Drug: GC4711 75mg Drug: GC4711 105mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 19, 2019

Actual Primary Completion Date :

Mar 4, 2020

Actual Study Completion Date :

Mar 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GC4711 30mg	Drug: GC4711 30mg single dose given via a 15 minute intravenous infusion
Experimental: GC4711 60mg	Drug: GC4711 60mg single dose given via a 15 minute intravenous infusion
Experimental: GC4711 90mg	Drug: GC4711 90mg single dose given via a 15 minute intravenous infusion
Experimental: GC4711 120mg	Drug: GC4711 120mg single dose given via a 15 minute intravenous infusion
Placebo Comparator: Placebo	Drug: Placebo single dose of normal saline given via a 15 minute intravenous infusion
Experimental: GC4711 75mg	Drug: GC4711 75mg single dose given via a 15 minute intravenous infusion
Experimental: GC4711 105mg	Drug: GC4711 105mg single dose given via a 15 minute intravenous infusion

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities [From randomization through study completion (estimated up to 3 days)]
Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours before the administration of study drug and throughout the the study;
Positive drug and alcohol toxicology screens during Screening
History of smoking or any use of a tobacco product within 6 months
Donation of blood or blood products within 30 days before Baseline and throughout the study;
Mentally unstable or incapable of being compliant with the protocol
Receipt of an investigational test substance within 3 months before the administration of study drugs, or anticipated receiving any study drugs
Subject has previously participated in this study, or in a prior Galera study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network	Melbourne	Victoria	Australia

Sponsors and Collaborators

Galera Therapeutics, Inc.

Investigators

Study Chair: Jon Holmlund, MD, Galera Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galera Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03762031

Other Study ID Numbers:

GTI-4711-002

First Posted:

Dec 3, 2018

Last Update Posted:

Aug 14, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 14, 2020