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

NCT03762031 | Completed Phase 1

• 1 other identifier: GTI-4711-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (7)

GC4711 30mg

EXPERIMENTAL

Drug: GC4711 30mg

GC4711 60mg

EXPERIMENTAL

Drug: GC4711 60mg

GC4711 90mg

EXPERIMENTAL

Drug: GC4711 90mg

GC4711 120mg

EXPERIMENTAL

Drug: GC4711 120mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

GC4711 75mg

EXPERIMENTAL

Drug: GC4711 75mg

GC4711 105mg

EXPERIMENTAL

Drug: GC4711 105mg

Interventions

GC4711 30mg DRUG

single dose given via a 15 minute intravenous infusion

GC4711 30mg

GC4711 60mg DRUG

single dose given via a 15 minute intravenous infusion

GC4711 60mg

GC4711 90mg DRUG

single dose given via a 15 minute intravenous infusion

GC4711 90mg

GC4711 120mg DRUG

single dose given via a 15 minute intravenous infusion

GC4711 120mg

Placebo DRUG

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

Placebo

GC4711 75mg DRUG

single dose given via a 15 minute intravenous infusion

GC4711 75mg

GC4711 105mg DRUG

single dose given via a 15 minute intravenous infusion

GC4711 105mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galera Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, Australia

Location

Study Officials

• Jon Holmlund, MD

  Galera Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: March 19, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)