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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: GC4711 30mg
* Drug: GC4711 60mg
* Drug: GC4711 90mg
* Drug: GC4711 120mg
* Drug: Placebo
* Drug: GC4711 75mg
* Drug: GC4711 105mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC4711 30mg<br> | Drug: GC4711 30mg<br>* single dose given via a 15 minute intravenous infusion<br>|
| Experimental: GC4711 60mg<br> | Drug: GC4711 60mg<br>* single dose given via a 15 minute intravenous infusion<br>|
| Experimental: GC4711 90mg<br> | Drug: GC4711 90mg<br>* single dose given via a 15 minute intravenous infusion<br>|
| Experimental: GC4711 120mg<br> | Drug: GC4711 120mg<br>* single dose given via a 15 minute intravenous infusion<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single dose of normal saline given via a 15 minute intravenous infusion<br>|
| Experimental: GC4711 75mg<br> | Drug: GC4711 75mg<br>* single dose given via a 15 minute intravenous infusion<br>|
| Experimental: GC4711 105mg<br> | Drug: GC4711 105mg<br>* single dose given via a 15 minute intravenous infusion<br>|

What is the study measuring?
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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) |