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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762031
Other study ID # GTI-4711-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 19, 2019
Est. completion date March 4, 2020

Study information

Verified date August 2020
Source Galera Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 4, 2020
Est. primary completion date March 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GC4711 30mg
single dose given via a 15 minute intravenous infusion
GC4711 60mg
single dose given via a 15 minute intravenous infusion
GC4711 90mg
single dose given via a 15 minute intravenous infusion
GC4711 120mg
single dose given via a 15 minute intravenous infusion
Placebo
single dose of normal saline given via a 15 minute intravenous infusion
GC4711 75mg
single dose given via a 15 minute intravenous infusion
GC4711 105mg
single dose given via a 15 minute intravenous infusion

Locations

Country Name City State
Australia Nucleus Network Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Galera Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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