Recruiting PHASE1, PHASE2 Healthy Participants

New treatment option for Healthy Participants

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

ClinicalTrials.gov ID: NCT07427680

What this study is testing

What is TGM-312-SC01?

TGM-312-SC01 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy participants.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70. Healthy volunteers may be eligible.

You may be able to join if

  • 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...

You likely can't join if

  • Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk...
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • London, United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.