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

Phase 2RecruitingNCT07427680

Tangram Therapeutics Plc99 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Participants MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions

TGM-312-SC01DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Richmond Pharmacology

London, United Kingdom

RECRUITING

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)

Maximum observed plasma concentration derived from plasma concentration-time data.

Time frame: 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)

Area under the plasma concentration-time curve derived from plasma concentration-time data.

Time frame: 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

Change from baseline in mRNA expression levels of the target gene in homogenised tissue samples following administration of TGM-312-SC01, expressed as relative change from baseline.

Time frame: 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

Change from baseline in protein levels of the target gene product in homogenised tissue samples following administration of TGM-312-SC01, expressed as concentration or relative change from baseline.

Time frame: From start of study drug administration through 16 weeks after the last study drug administration.

Central Contacts

Sponsor Clinical Trials Office

CONTACT

+44 20 4558 3826 clinicaltrials@tangramtx.com

Data from ClinicalTrials.gov

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