| NCT ID | NCT06828393 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Seismic Therapeutic AU Pty Ltd |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-03 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2025-03 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06828393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06828393 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06828393 currently recruiting?
Yes, NCT06828393 is actively recruiting participants. Contact the research team at clinical@seismictx.com for enrollment information.
Where is the NCT06828393 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT06828393 clinical trial?
NCT06828393 is sponsored by Seismic Therapeutic AU Pty Ltd. The trial plans to enroll 96 participants.