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

NCT ID: NCT03762031

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2020-03-04

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GC4711 30mg

Group Type: EXPERIMENTAL

GC4711 30mg

Intervention Type: DRUG

single dose given via a 15 minute intravenous infusion

GC4711 60mg

Group Type: EXPERIMENTAL

GC4711 60mg

Intervention Type: DRUG

single dose given via a 15 minute intravenous infusion

GC4711 90mg

Group Type: EXPERIMENTAL

GC4711 90mg

Intervention Type: DRUG

single dose given via a 15 minute intravenous infusion

GC4711 120mg

Group Type: EXPERIMENTAL

GC4711 120mg

Intervention Type: DRUG

single dose given via a 15 minute intravenous infusion

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single dose of normal saline given via a 15 minute intravenous infusion

GC4711 75mg

Group Type: EXPERIMENTAL

GC4711 75mg

Intervention Type: DRUG

single dose given via a 15 minute intravenous infusion

GC4711 105mg

Group Type: EXPERIMENTAL

GC4711 105mg

Intervention Type: DRUG

single dose given via a 15 minute intravenous infusion

Interventions

GC4711 30mg

single dose given via a 15 minute intravenous infusion

Intervention Type: DRUG

GC4711 60mg

single dose given via a 15 minute intravenous infusion

Intervention Type: DRUG

GC4711 90mg

single dose given via a 15 minute intravenous infusion

Intervention Type: DRUG

GC4711 120mg

single dose given via a 15 minute intravenous infusion

Intervention Type: DRUG

Placebo

single dose of normal saline given via a 15 minute intravenous infusion

Intervention Type: DRUG

GC4711 75mg

single dose given via a 15 minute intravenous infusion

Intervention Type: DRUG

GC4711 105mg

single dose given via a 15 minute intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galera Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Holmlund, MD

Role: STUDY_CHAIR

Galera Therapeutics, Inc.

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

GTI-4711-002

Identifier Type: -

Identifier Source: org_study_id