First human trial of S-4321 for safety and tolerability

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 clinical trial is a Phase 1, randomized, placebo-controlled, double-blind study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-4321 in healthy adult volunteers. The study consists of two parts: Part 1 involves single ascending doses (SAD), while Part 2 focuses on multiple ascending doses (MAD). Participants will receive either the investigational drug or a placebo, and their responses will be closely monitored throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Is available for the entire duration of the study and follow up.
2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
4. Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
5. Is in good physical and mental health in the opinion of the Investigator or delegate.

Major Exclusion Criteria:

1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
3. Has a known immunodeficiency disorder.
4. Has a history of malignancy or confirmed cervical dysplasia.
5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
6. Has positive laboratory evidence for active hepatitis at screening.
7. Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.

Other inclusion/exclusion eligibility criteria apply.

Where it's running

• Veritus Research
  Bayswater, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Seismic Contact
• Email: clinical@seismictx.com
• Phone: 1800 244 475

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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.