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RECRUITING
NCT07427680
PHASE1/PHASE2

Study of TGM-312-SC01 in Healthy Participants and Adults With MASH

Sponsor: Tangram Therapeutics Plc

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2026-02

Completion Date

2028-06

Last Updated

2026-03-27

Healthy Volunteers

Yes

Interventions

DRUG

TGM-312-SC01

TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.

DRUG

Placebo

Placebo administered by subcutaneous injection according to a protocol-defined regimen.

Locations (1)

Clinical Site 1

London, United Kingdom