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

Phase 1

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: GM-60106; Other: Placebo

• Registration Number: NCT05517564
• Lead Sponsor: JD Bioscience Inc.

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.

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 Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25
• Primary Completion: 2023-02-28
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
A (GM-60106)	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
B (Placebo)	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

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability of GM-60106 through incidence, nature, and severity of adverse events (AEs)	Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days

Secondary Outcome Measures

Name	Time	Method
The pharmacokinetics (PK) of GM-60106. Plasma sample will be collected for PK assessment. Parameter: maximum concentration (Cmax)	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)	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)	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)	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).	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])	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])	Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days

Trial Locations

Locations (1)

Nucleus Network Pty Ltd; 🇦🇺 Melbourne, Victoria, Australia