Status:
RECRUITING
A Phase 1 Study of S-4321
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-4321 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, pharmacodynamics of S-4321 administered to healthy adult participants. This study wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06877611
Start Date
April 3 2025
End Date
April 1 2026
Last Update
April 15 2025
Active Locations (1)
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1
Veritus Research
Bayswater, Victoria, Australia