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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03194139




Registration number
NCT03194139
Ethics application status
Date submitted
19/06/2017
Date registered
21/06/2017
Date last updated
14/02/2018

Titles & IDs
Public title
A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Double-Blind, Crossover, Single Dose Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers
Secondary ID [1] 0 0
GTI-4711-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GC4711 30 mg IV
Treatment: Drugs - GC4711 50 mg IV
Treatment: Drugs - GC4419 45 mg IV

Experimental: Sentinel Cohort -

Experimental: Crossover Design -


Treatment: Drugs: GC4711 30 mg IV
GC4711 will be infused IV as a single dose of 30 mg (3 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump

Treatment: Drugs: GC4711 50 mg IV
GC4711 will be infused IV as a single dose of 50 mg (5 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totalling 250 mL, over a 60-minute period using a programmable pump.

Treatment: Drugs: GC4419 45 mg IV
GC4419 will be infused IV as a single dose of 45 mg (5 mL GC4419 at 9 mg/mL) in 245 mL normal (0.9%) saline, totalling 250 mL, over a 60-minute period using a programmable pump.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency, duration, and severity of adverse events (AEs)
Timepoint [1] 0 0
From first dose of study medication until up to 3 days post last dose. Up to 6 days total
Primary outcome [2] 0 0
Incidence of clinically significant laboratory abnormalities
Timepoint [2] 0 0
From first dose of study medication until up to 3 days post last dose. Up to 6 days total

Eligibility
Key inclusion criteria
1. Healthy men and women between 18 and 50 years (inclusive) of age;

2. Subjects who provide written informed consent to participate in the study

3. Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during
Screening and at Baseline.

4. Subjects in general good health

5. Chest X-ray free of clinically significant abnormalities

6. Blood pressure and heart rate within normal limits

7. Female subjects must:

1. Have a negative pregnancy test during Screening and Baseline

2. Be non-lactating

3. Be at least two 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, disease, medical condition, or laboratory
abnormality

2. Known hypersensitivity and/or allergy to study drugs

3. Use of any prescription or over-the-counter medication within one week prior to
baseline;

4. Anticipated need for any medication during the course of the study

5. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5)
inhibitors (e.g., sildenafil, tadalafil, or similar agents), from 24 hours prior to
screening throughout participation in the study;

6. Use of or other drugs that may, in the judgment of the treating investigator, create a
risk for a precipitous decrease in blood pressure, from 24 hours prior to screening
throughout participation in the study;

7. Use of any vitamin or mineral supplement 24 hours prior to dosing, or anticipated use
of any vitamin or mineral supplement throughout the duration of the study;

8. Positive HIV, Hepatitis B or Hepatitis C

9. Known history of substance abuse, drug addiction, or alcoholism within 3 years prior
to Baseline;

10. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours
prior to the administration of study drug and throughout the duration of the study;

11. History of smoking or any use of a tobacco product within six months prior to
Baseline;

12. Donation of blood or blood products within 30 days prior to the Baseline;

13. Receipt of an investigational test substance within three months prior to the first
dose of study drugs or anticipated receiving any study drugs (including placebo on
another investigational study)

14. Subject has previously participated in this study, or in a prior study of GC4419 or
GC4702.

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
Crossover
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
25/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/12/2017
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galera Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study will be a double-blind, randomized, crossover, single-dose assessment of
IV-administered GC4711 compared to GC4419 in healthy volunteers.

Consenting subjects will undergo screening procedures within 28 days of the start of dosing.
Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine
from all subjects.

Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will
receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety
review by the Galera study team , if no safety concerns are identified after the last subject
completes study participation, enrollment will continue in 2 stages to a crossover study
design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are
identified in stage 1 following a clinical safety review by the Galera study team, 20
subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover
design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) ->
Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first
treatment they were randomized to, and on Day 4 (following a washout), they will receive the
second treatment. Subjects will be followed up for 2 days after the second treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03194139
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon T Holmlund, MD
Address 0 0
Galera Therapeutics
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03194139