Status:
COMPLETED
A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Lead Sponsor:
Galera Therapeutics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 mimeti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03762031
Start Date
March 19 2019
End Date
March 4 2020
Last Update
August 14 2020
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia