RESTORE-MASH: A Phase 1/2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
Study Overview
Brief 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).
Detailed Description
This is a Phase 1/2, randomised, masked, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of TGM-312-SC01 administered by subcutaneous injection. The study includes a single ascending dose component in healthy participants and a multiple ascending dose component in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
TGM-312-SC01
Participants will receive study treatment according to the assigned intervention.
Intervention: TGM-312-SC01 (Drug)
Placebo
Participants will receive study treatment according to the assigned intervention.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
Time Frame: From start of study drug administration through 16 weeks after the last study drug administration.
Secondary Outcomes
- Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)(From start of study drug administration through 48 hours after the last study drug administration.)
- Area under the plasma concentration-time curve (AUC) of TGM-312-SC01 (ng·h/mL)(From start of study drug administration through 48 hours after the last study drug administration.)
- Change from baseline in target gene mRNA expression levels in tissue homogenate(From start of study drug administration through 16 weeks after the last study drug administration.)
- Change from baseline in target protein levels in tissue homogenate(From start of study drug administration through 16 weeks after the last study drug administration.)