TGM-148: TGM-148 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
Placebo: Placebo administered by subcutaneous injection according to a protocol-defined regimen.
Study summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-148 in healthy adults
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Frequency and severity of adverse events [Safety and tolerability] — From start of study drug administration through 16 weeks after study drug administration.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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