Actively Recruiting
A Phase 1 Study of S-4321
Led by Seismic Therapeutic AU Pty Ltd · Updated on 2025-04-15
96
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
S
Seismic Therapeutic AU Pty Ltd
Lead Sponsor
A
Avance Clinical Pty Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
CONDITIONS
Official Title
A Phase 1 Study of S-4321
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Available for the entire duration of the study and follow-up
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions
- Voluntarily consents to participate by signing the informed consent form
- Has a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weighs at least 45 kg
- Is in good physical and mental health as judged by the Investigator or delegate
You will not qualify if you...
- History of severe allergic or anaphylactic reaction as determined by the Investigator or delegate
- Pregnant, nursing, or planning to become pregnant or breastfeed during the trial
- Known immunodeficiency disorder
- History of malignancy or confirmed cervical dysplasia
- History of HIV or positive HIV serology at screening
- Positive laboratory evidence for active hepatitis at screening
- Any other condition or prior therapy that may compromise safety, compliance, or study completion in the opinion of the Investigator or delegate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia
Actively Recruiting
Research Team
S
Seismic Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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