A 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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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