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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Nucleus Network Pty Ltd
Geelong, Victoria, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
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
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])
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Time frame: Part A: Up to 43 days, Part B: Up to 49 days, Part C: Up to 63 days