TGM-312-SC01: TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
Placebo: Placebo administered by subcutaneous injection according to a protocol-defined regimen.
Study summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Adults aged 18 to 70 years who are able to provide written informed consent.
* Medically suitable for study participation based on protocol-defined assessments.
* For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.
Exclusion Criteria:
* 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.
* Recent participation in another investigational study.
* Use of medications that are prohibited by the protocol.
* Any other condition that would make the individual unsuitable for study participation as determined by the investigator.
Primary outcome measure(s)
Incidence and severity of treatment-emergent adverse events [Safety and tolerability] — From start of study drug administration through 16 weeks after the last study drug administration.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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