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

NCT05517564 | Unknown Phase 1 DMC

• 1 other identifier: JDB-106001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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. 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: 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. 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

Study Arms (2)

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

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

Other: Placebo

Interventions

GM-60106 DRUG

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.

A (GM-60106)

Placebo OTHER

Placebo-to-match GM-60106 capsules

B (Placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JD Bioscience Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (2)

Nucleus Network Pty Ltd

Geelong, Victoria, 3220, Australia

Location

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Sam Francis

  Nucleus Network Pty Ltd -Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2023
• Last Updated: October 25, 2022

Record last verified: 2022-08

Locations

AU (2)