First human trial of S-4321 for safety and tolerability

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers

This study is testing a new drug called S-4321 to see if it's safe and how well it works in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Seismic Therapeutic AU Pty Ltd (Industry-sponsored)
• Locations: 1 site (Bayswater, Victoria)
• Trial ID: NCT06877611 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 32 kg/m2.

Not a fit: Patients with a history of severe allergies, immunodeficiency disorders, or certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide critical safety and efficacy data for S-4321, paving the way for its use in future treatments.

How similar studies have performed: While this is a first-in-human trial for S-4321, similar Phase 1 studies have successfully established safety profiles for other investigational drugs.

Eligibility criteria

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 this trial is running

Bayswater, Victoria

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

Study contacts

• Study coordinator: Seismic Contact

Conditions Healthy Volunteer