Status:

RECRUITING

A Phase 1 Study of S-1117

Lead Sponsor:

Seismic Therapeutic AU Pty Ltd

Collaborating Sponsors:

Avance Clinical Pty Ltd.

Conditions:

Healthy Volunteer

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Detailed Description

This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of S-1117 administered to healthy adult participants. This study...

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.

Key Trial Info

Start Date :

March 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT06828393

Start Date

March 1 2025

End Date

March 1 2026

Last Update

March 12 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

CMAX Clinical Research

Adelaide, South Australia, Australia, 5000

A Phase 1 Study of S-1117 | DecenTrialz