Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
99 (estimated)
Sponsor
Tangram Therapeutics Plc · Industry
Who this trial is looking for
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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).
Trial Locations
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Eligibility Criteria
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 steat…
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.
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