A first-in-human, Phase I/II, randomized, masked, placebo-controlled, parallel-group, dose-escalation, adaptive study to evaluate the safety and pharmacokinetics of a single dose of TGM-312-SC01 in healthy participants and the safety, pharmacokinetics, pharmacodynamics and early signs of efficacy of multiple doses of TGM-312-SC01 in people with metabolic dysfunction-associated steatohepatitis (MASH)
Metabolic dysfunction-associated steatohepatitis (MASH)
Participants will receive either the trial medication (TGM-312-SC01) or placebo via subcutaneous injection. Participants will be randomised to receive TGM-312-SC01 or placebo in a 1:1 ratio in Part A and 2:1 ratio for Parts B and C. Participants in Part A will receive the trial treatment once, participants in Parts B and C will receive the trial treatment twice, 4 weeks apart. Doses for Part A are proposed as 15, 45, 100, 200, 400 and 600 mg. The dose for Part B/C will decided upon review of the data from Part A.
1. Adults aged 18 to 70 years 2. Able to provide written informed consent 3. Medically suitable for study participation based on protocol-defined assessments For the disease cohort, participants must have clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol
1. Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results 2. Recent participation in another investigational study 3. Use of medications that are prohibited by the protocol 4. Any other condition that would make the individual unsuitable for study participation as determined by the investigator