MST-931 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 1a trial is a randomized, double-blind, placebo-controlled study in healthy volunteers aged 18–55. It will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity after a single dose of MST-931 versus placebo. MST-931 is a monoclonal antibody being studied in healthy participants before testing in patients. The study uses dose-escalation or fixed-dose cohorts to characterize initial safety and biological responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects must meet the following criteria to be eligible for study entry:

  1. Healthy male or female subjects age ≥ 18 and ≤ 55 years.
  2. Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
  3. Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
  4. Signed Informed consent form for participation in the study.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from study entry

  1. Hypersensitivity to the Investigational Medicinal Product (IMP) or any of its components, to biological agents, or prior history of severe drug hypersensitivity reactions.
  2. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunologic, dermatologic, psychiatric or neurological disease, or other significant clinical findings within 3 months before screening.
  3. History of malignancy within 5 years prior to screening, with the exception of patients with a negligible risk of metastases or death and/or treated with expected curative outcome.
  4. Family history of premature Coronary Heart Disease.
  5. Pregnant or Breastfeeding subject, women with positive pregnancy test (hCG).
  6. Unlikely to comply with the clinical study protocol.

Where it's running

• Q-Pharm Pty Ltd
  Herston, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Changlong Liu
• Email: changlong.liu@mabsoftbio.com
• Phone: +86-15810213012

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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.