Healthy VolunteersPhase 1NCT03194139
A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers
A Phase 1 study testing GC4711 30 mg IV, GC4711 50 mg IV and GC4419 45 mg IV in people with Healthy Volunteers and Healthy, run by Galera Therapeutics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Healthy
- What is being tested?
- GC4711 30 mg IV, GC4711 50 mg IV and GC4419 45 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Sep 2017to 24 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between 18 and 50 years (inclusive) of age;
- Subjects who provide written informed consent to participate in the study
- Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline.
- Subjects in general good health
- Chest X-ray free of clinically significant abnormalities
- Blood pressure and heart rate within normal limits
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- Female subjects must:
- Have a negative pregnancy test during Screening and Baseline
- Be non-lactating
- Be at least two years postmenopausal, surgically sterile or practicing effective contraception
Who cannot join
- History of clinically significant illness, disease, medical condition, or laboratory abnormality
- Known hypersensitivity and/or allergy to study drugs
- Use of any prescription or over-the-counter medication within one week prior to baseline;
- Anticipated need for any medication during the course of the study
- 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;
- 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;
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- 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;
- Positive HIV, Hepatitis B or Hepatitis C
- Known history of substance abuse, drug addiction, or alcoholism within 3 years prior to Baseline;
- 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;
- History of smoking or any use of a tobacco product within six months prior to Baseline;
- Donation of blood or blood products within 30 days prior to the Baseline;
- 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)
- Subject has previously participated in this study, or in a prior study of GC4419 or GC4702.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy Volunteers, Healthy
- Being tested
- GC4711 30 mg IV, GC4711 50 mg IV, GC4419 45 mg IV
- Keywords
- Healthy Adult, Superoxide Dismutase, First in Human, Free Radical Dismutase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC4711 30 mg IVDrug
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
GC4711 50 mg IVDrug
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.
GC4419 45 mg IVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Cohort | Experimental | Not described Receives: Drug: GC4711 30 mg IV |
| Crossover Design | Experimental | Not described Receives: Drug: GC4711 50 mg IV; Drug: GC4419 45 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, duration, and severity of adverse events (AEs)
Measured: From first dose of study medication until up to 3 days post last dose. Up to 6 days total
Incidence of clinically significant laboratory abnormalities
Measured: From first dose of study medication until up to 3 days post last dose. Up to 6 days total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start25 Sep 2017
- Primary completion24 Dec 2017
- Study completion24 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Jon T Holmlund, MD, Study chair, Galera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194139
- Sponsor's protocol ID
- GTI-4711-001
- Status last verified
- Feb 2018
- First submitted
- 19 Jun 2017
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03194139
- Acronym / sponsor ID
- GTI-4711-001
- Conditions
- Healthy Volunteers, Healthy
- Keywords
- Healthy Adult, Superoxide Dismutase, First in Human, Free Radical Dismutase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 24 Dec 2017 (actual)
- Study completion
- 24 Dec 2017 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel Cohort | Experimental | Drug: GC4711 30 mg IV |
| Crossover Design | Experimental | Drug: GC4711 50 mg IV, Drug: GC4419 45 mg IV |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy men and women between 18 and 50 years (inclusive) of age;
- Subjects who provide written informed consent to participate in the study
- Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline.
- Subjects in general good health
- Chest X-ray free of clinically significant abnormalities
Key exclusion criteria (14 listed)
- History of clinically significant illness, disease, medical condition, or laboratory abnormality
- Known hypersensitivity and/or allergy to study drugs
- Use of any prescription or over-the-counter medication within one week prior to baseline;
- Anticipated need for any medication during the course of the study
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC4711 30 mg IVGC4711 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 | Drug | Sentinel Cohort |
| GC4711 50 mg IVGC4711 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. | Drug | Crossover Design |
| GC4419 45 mg IVGC4419 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. | Drug | Crossover Design |
Primary outcome
Frequency, duration, and severity of adverse events (AEs)
Time frame: From first dose of study medication until up to 3 days post last dose. Up to 6 days total
Incidence of clinically significant laboratory abnormalities
Time frame: From first dose of study medication until up to 3 days post last dose. Up to 6 days total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon T Holmlund, MD study chair
Galera Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC4711 30 mg IV, GC4711 50 mg IV and GC4419 45 mg IV in people with Healthy Volunteers and Healthy, run by Galera Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, duration, and severity of adverse events (AEs) (time frame: From first dose of study medication until up to 3 days post last dose. Up to 6 days total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.