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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GC4711 30mg; Drug: GC4711 60mg; Drug: GC4711 90mg; Drug: GC4711 120mg; Drug: Placebo; Drug: GC4711 75mg; Drug: GC4711 105mg

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy men and women between 18 and 50 years
2. Subjects who provide written informed consent
3. Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
4. Subjects in general good health
5. Blood pressure and pulse within normal limits
6. Male subjects must practice effective contraception

7. 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:

1. History of clinically significant illness or medical history which would preclude them from the study.
2. Known contraindication, hypersensitivity and/or allergy to study drugs
3. Use of any prescription or over-the-counter medication within one week prior to study drug administration
4. Anticipated need for any medication during the study
5. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors
6. Use of other drugs that may, in the judgment of the Investigator, create a risk for a precipitous decrease in blood pressure
7. Presence of orthostatic hypotension at screening
8. Use of any vitamin or mineral supplement 24 hours before dosing or throughout study
9. Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
10. Known history of substance abuse, drug addiction, or alcoholism within 3 years
11. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours before the administration of study drug and throughout the the study;
12. Positive drug and alcohol toxicology screens during Screening
13. History of smoking or any use of a tobacco product within 6 months
14. Donation of blood or blood products within 30 days before Baseline and throughout the study;
15. Mentally unstable or incapable of being compliant with the protocol
16. Receipt of an investigational test substance within 3 months before the administration of study drugs, or anticipated receiving any study drugs
17. Subject has previously participated in this study, or in a prior Galera study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; single dose of normal saline given via a 15 minute intravenous infusion
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities	Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities	From randomization through study completion (estimated up to 3 days)

Collaborators and Investigators

• Sponsor: Galera Therapeutics, Inc.
• Investigators: Study Chair: Jon Holmlund, MD, Galera Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GTI-4711-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No