Healthy
Conditions
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.
Interventions
DRUGGC4711 30mg
single dose given via a 15 minute intravenous infusion
DRUGGC4711 60mg
single dose given via a 15 minute intravenous infusion
DRUGGC4711 90mg
single dose given via a 15 minute intravenous infusion
DRUGGC4711 120mg
single dose given via a 15 minute intravenous infusion
DRUGPlacebo
single dose of normal saline given via a 15 minute intravenous infusion
DRUGGC4711 75mg
single dose given via a 15 minute intravenous infusion
DRUGGC4711 105mg
single dose given via a 15 minute intravenous infusion
Sponsors
Galera Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities | From randomization through study completion (estimated up to 3 days) | Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities |
Countries
Australia
Outcome results
None listed