Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTangram Therapeutics Plc
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TGM-312-SC01
- Placebo
Treatment groups
99 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov