Non-alcoholic SteatohepatitisPhase 1NCT05517564
First-in-Human Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease
A Phase 1 study testing GM-60106 in people with Non-alcoholic Steatohepatitis, run by JD Bioscience Inc. at 2 sites in Australia.
Trial summary
This is a Phase 1a/1b, randomised, double-blind, placebo-controlled single- and multiple-ascending dose study to evaluate the safety, tolerability, PK, and PD of GM-60106 in healthy adult male and female participants and otherwise healthy adults who have an increased BMI and markers of NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- GM-60106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Aug 2022to 30 Jun 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females aged 18 to 55 years (inclusive)
- Body weight ≥ 50 kg for males and ≥ 45 kg for females
- Negative pregnancy test
Who cannot join
- History or presence of clinically significant abnormalities or participants with psychosomatic disorders.
- Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibody.
- Dosing in other clinical studies and treatment with a study drug within 3 months prior to IP administration.
- Females who are pregnant or breastfeeding, or of childbearing potential who are not using effective non-hormonal contraception; men of childbearing potential who are unwilling to use physical methods of contraception during the study
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network Pty Ltd
Geelong, Victoria, 3220
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
About this study
Official title: A Phase 1, First-in-Human, Double-blind, Placebo-controlled, Single-and Multiple-Ascending Oral Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease
This is a Phase 1a/1b, randomised, double-blind, placebo-controlled single- and multiple-ascending dose study to evaluate the safety, tolerability, PK, and PD of GM-60106 in healthy adult male and female participants and otherwise healthy adults who have an increased BMI and markers of NAFLD.
Read the detailed description
The study consists of 3 parts:
Part A (Single Ascending Dose [SAD]): Approximately 56 healthy participants will be enrolled into 7 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).
Part B (Multiple Ascending Dose [MAD]): Approximately 24 healthy participants will be enrolled into 3 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).
Part C (Multiple Ascending Dose [MAD]): Approximately 16 participants will be enrolled into 2 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo). Cohorts will include otherwise healthy participants who have an increased BMI and markers of NAFLD.
Part B and Part C will occur only after the Safety Monitoring Committee (SMC) has reviewed all blinded safety data as well as any available PK and PD data from MAD cohorts that have completed the assessment of doses equal to the proposed starting Part C (MAD) dose and a dose higher (including a minimum safety review interval of 10 days after dosing the sixth participant in the cohort) and recommends initiation.
The study duration for each participant in Part A (SAD) is a maximum of 36 to 43 days, including a Screening period of up to 28 days, 1 day of single dosing, and a follow-up period of 7 days for most cohorts, and food effect assessment with a total treatment and follow-up period of 15 days for one of the SAD cohorts.
The study duration for each participant in Part B (MAD) is a maximum of 49 days, including a Screening period of up to 28 days, 14 consecutive days of once daily dosing, and a follow-up period of 7 days.
The study duration for each participant in Part C (MAD) is a maximum of 63 days, including a Screening period of up to 28 days, 28 consecutive days of once daily dosing, and a follow-up period of 7 days.
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- GM-60106, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-60106Drug
The participants will receive a single oral dose between 2.5 to 100 mg for Part A (SAD), Part B (MAD) once daily for 14 days, and for Part C (MAD) once daily for 28 days.
PlaceboOther
Placebo-to-match GM-60106 capsules
| Study group | Role | What they receive |
|---|---|---|
| A (GM-60106) | Experimental | Drug: GM-60106 Dosage: Part A: 2.5, 5, 10, 20, 40, 60, or 100 mg, Part B: 5, 10, 20 mg, Part C: 10, 20 mg Dosage Form: Bovine-gelatin capsules Route of Administration: Oral Receives: Drug: GM-60106 |
| B (Placebo) | Experimental | Dosage Form: Bovine-gelatin capsules Route of Administration: Oral Matching placebo has an identical formulation to the GM-60106 drug product, prepared without the active pharmaceutical ingredient Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs)
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcomes (7)
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: maximum concentration (Cmax)
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: time to maximum concentration (Tmax)
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: Area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last)
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Cumulative amount of drug excreted in urine (Ae)
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Renal clearance (CLr).
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacodynamics (PD) of GM-60106 through liver function test (aspartate aminotransferase [AST])
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacodynamics (PD) of GM-60106 through liver function test (alanine aminotransferase [ALT])
Measured: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Aug 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JD Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Sam Francis, Principal investigator, Nucleus Network Pty Ltd -Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517564
- Sponsor's protocol ID
- JDB-106001
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Double-blind, Placebo-controlled, Single-and Multiple-Ascending Oral Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05517564
- Acronym / sponsor ID
- JDB-106001
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- JD Bioscience Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Aug 2022 (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.
This is a Phase 1a/1b, randomised, double-blind, placebo-controlled single- and multiple-ascending dose study to evaluate the safety, tolerability, PK, and PD of GM-60106 in healthy adult male and female participants and otherwise healthy adults who have an increased BMI and markers of NAFLD.
Detailed description
The study consists of 3 parts:
Part A (Single Ascending Dose [SAD]): Approximately 56 healthy participants will be enrolled into 7 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).
Part B (Multiple Ascending Dose [MAD]): Approximately 24 healthy participants will be enrolled into 3 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).
Part C (Multiple Ascending Dose [MAD]): Approximately 16 participants will be enrolled into 2 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo). Cohorts will include otherwise healthy participants who have an increased BMI and markers of NAFLD.
Part B and Part C will occur only after the Safety Monitoring Committee (SMC) has reviewed all blinded safety data as well as any available PK and PD data from MAD cohorts that have completed the assessment of doses equal to the proposed starting Part C (MAD) dose and a dose higher (including a minimum safety review interval of 10 days after dosing the sixth participant in the cohort) and recommends initiation.
The study duration for each participant in Part A (SAD) is a maximum of 36 to 43 days, including a Screening period of up to 28 days, 1 day of single dosing, and a follow-up period of 7 days for most cohorts, and food effect assessment with a total treatment and follow-up period of 15 days for one of the SAD cohorts.
The study duration for each participant in Part B (MAD) is a maximum of 49 days, including a Screening period of up to 28 days, 14 consecutive days of once daily dosing, and a follow-up period of 7 days.
The study duration for each participant in Part C (MAD) is a maximum of 63 days, including a Screening period of up to 28 days, 28 consecutive days of once daily dosing, and a follow-up period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (GM-60106) | Experimental | Drug: GM-60106Drug: GM-60106 Dosage: Part A: 2.5, 5, 10, 20, 40, 60, or 100 mg, Part B: 5, 10, 20 mg, Part C: 10, 20 mg Dosage Form: Bovine-gelatin capsules Route of Administration: Oral |
| B (Placebo) | Experimental | Other: PlaceboDosage Form: Bovine-gelatin capsules Route of Administration: Oral Matching placebo has an identical formulation to the GM-60106 drug product, prepared without the active pharmaceutical ingredient |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males or females aged 18 to 55 years (inclusive)
- Body weight ≥ 50 kg for males and ≥ 45 kg for females
- Negative pregnancy test
Key exclusion criteria (4 listed)
- History or presence of clinically significant abnormalities or participants with psychosomatic disorders.
- Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibody.
- Dosing in other clinical studies and treatment with a study drug within 3 months prior to IP administration.
- Females who are pregnant or breastfeeding, or of childbearing potential who are not using effective non-hormonal contraception; men of childbearing potential who are unwilling to use physical methods of contraception during 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 |
|---|---|---|
| GM-60106The participants will receive a single oral dose between 2.5 to 100 mg for Part A (SAD), Part B (MAD) once daily for 14 days, and for Part C (MAD) once daily for 28 days. | Drug | A (GM-60106) |
| PlaceboPlacebo-to-match GM-60106 capsules | Other | B (Placebo) |
Primary outcome
To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs)
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
7 secondary outcomes
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: maximum concentration (Cmax)
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: time to maximum concentration (Tmax)
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: Area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last)
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Cumulative amount of drug excreted in urine (Ae)
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Renal clearance (CLr).
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacodynamics (PD) of GM-60106 through liver function test (aspartate aminotransferase [AST])
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
The pharmacodynamics (PD) of GM-60106 through liver function test (alanine aminotransferase [ALT])
Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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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.
Sam Francis principal investigator
Nucleus Network Pty Ltd -Melbourne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GM-60106 in people with Non-alcoholic Steatohepatitis, run by JD Bioscience Inc. at 2 sites 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs) (time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days). 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 25 Oct 2022.