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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03762031




Registration number
NCT03762031
Ethics application status
Date submitted
30/11/2018
Date registered
3/12/2018

Titles & IDs
Public title
A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Scientific title
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
Secondary ID [1] 0 0
GTI-4711-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GC4711 30mg
Treatment: Drugs - GC4711 60mg
Treatment: Drugs - GC4711 90mg
Treatment: Drugs - GC4711 120mg
Treatment: Drugs - Placebo
Treatment: Drugs - GC4711 75mg
Treatment: Drugs - GC4711 105mg

Experimental: GC4711 30mg -

Experimental: GC4711 60mg -

Experimental: GC4711 90mg -

Experimental: GC4711 120mg -

Placebo comparator: Placebo -

Experimental: GC4711 75mg -

Experimental: GC4711 105mg -


Treatment: Drugs: GC4711 30mg
single dose given via a 15 minute intravenous infusion

Treatment: Drugs: GC4711 60mg
single dose given via a 15 minute intravenous infusion

Treatment: Drugs: GC4711 90mg
single dose given via a 15 minute intravenous infusion

Treatment: Drugs: GC4711 120mg
single dose given via a 15 minute intravenous infusion

Treatment: Drugs: Placebo
single dose of normal saline given via a 15 minute intravenous infusion

Treatment: Drugs: GC4711 75mg
single dose given via a 15 minute intravenous infusion

Treatment: Drugs: GC4711 105mg
single dose given via a 15 minute intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities
Timepoint [1] 0 0
From randomization through study completion (estimated up to 3 days)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/03/2020
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galera Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon Holmlund, MD
Address 0 0
Galera Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03762031