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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/NCT05517564




Registration number
NCT05517564
Ethics application status
Date submitted
24/08/2022
Date registered
26/08/2022
Date last updated
25/10/2022

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
JDB-106001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GM-60106
Other interventions - Placebo

Experimental: A (GM-60106) - 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

Experimental: B (Placebo) - 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


Treatment: Drugs: GM-60106
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.

Other interventions: Placebo
Placebo-to-match GM-60106 capsules
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs)
Timepoint [1] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [1] 0 0
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: maximum concentration (Cmax)
Timepoint [1] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [2] 0 0
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: time to maximum concentration (Tmax)
Timepoint [2] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [4] 0 0
The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Cumulative amount of drug excreted in urine (Ae)
Timepoint [4] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [5] 0 0
The pharmacokinetics (PK) of GM-60106. Urine sample will be collected for PK assessment. Parameter: Renal clearance (CLr).
Timepoint [5] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [6] 0 0
The pharmacodynamics (PD) of GM-60106 through liver function test (aspartate aminotransferase [AST])
Timepoint [6] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days
Secondary outcome [7] 0 0
The pharmacodynamics (PD) of GM-60106 through liver function test (alanine aminotransferase [ALT])
Timepoint [7] 0 0
Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days

Eligibility
Key inclusion criteria
Key inclusion Criteria:

1. Healthy adult males or females aged 18 to 55 years (inclusive)

2. Body weight = 50 kg for males and = 45 kg for females

3. Negative pregnancy test

Key exclusion criteria:

1. History or presence of clinically significant abnormalities or participants with
psychosomatic disorders.

2. Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B
surface antigen (HbsAg), or hepatitis C virus (HCV) antibody.

3. Dosing in other clinical studies and treatment with a study drug within 3 months prior
to IP administration.

4. 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Geelong
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
JD Bioscience Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05517564
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Francis
Address 0 0
Nucleus Network Pty Ltd -Melbourne
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/NCT05517564