A Phase 1 Study of S-4321

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Key facts

Study ID

NCT06877611

Run by

Seismic Therapeutic AU Pty Ltd

People needed

96

Starts

2025-04-03

Expected to finish

2026-04-01

Last updated by the study team

2025-04-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is available for the entire duration of the study and follow up.
• Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
• Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
• Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
• Is in good physical and mental health in the opinion of the Investigator or delegate.
• Major Exclusion Criteria:
• Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
• Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
• Has a known immunodeficiency disorder.
• Has a history of malignancy or confirmed cervical dysplasia.
• Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
• Has positive laboratory evidence for active hepatitis at screening.
• 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 is running

• Veritus Research — Bayswater, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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