First-in-human assessment of S-1117 in healthy volunteers

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers

This study is testing a new drug called S-1117 in healthy adults to see how safe it is and how it works in the body.

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 (Adelaide, South Australia)
• Trial ID: NCT06828393 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-1117 in healthy adult participants. It is a randomized, placebo-controlled, double-blind trial conducted in two parts: the first part involves single ascending doses, while the second part focuses on multiple ascending doses. The goal is to gather essential data on how S-1117 behaves in the human body and its potential effects.

Who should consider this trial

Good fit: Ideal candidates 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 study could provide critical safety and efficacy data that may lead to the development of new therapeutic options.

How similar studies have performed: Other first-in-human studies have shown success in assessing new compounds, making this approach a standard practice in drug development.

Eligibility criteria

Major 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 other than non-melanoma skin cancer.
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 received a live vaccine within 2 months of Screening.
8. 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

Adelaide, South Australia

• CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Seismic Contact

Conditions Healthy Volunteer