Safety, tolerability, and PK/PD of a single dose of TGM-148 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial is a first-in-human, randomized, double-masked, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous dose of TGM-148 in healthy participants. It uses a single ascending dose design to explore safety across increasing dose levels while comparing with placebo. The study is conducted at a single site and is sponsor-unmasked for the investigator to monitor safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy adults aged 18 to 45 years who are able to provide written informed consent.
* Medically suitable for study participation based on protocol-defined assessments.
* Body mass index (BMI) between 18.0-30.0 kg/m² (inclusive) and a body weight \>50 kg.

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.

Where it's running

• Hammersmith Medicines Research
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Sponsor Clinical Trials Office
• Email: clinicaltrials@tangramtx.com
• Phone: +44 20 4558 3826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.