Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06828393

A Phase 1 Study of S-1117

Led by Seismic Therapeutic AU Pty Ltd · Updated on 2025-03-12

96

Participants Needed

1

Research Sites

52 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-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

CONDITIONS

Official Title

A Phase 1 Study of S-1117

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Available for the entire study duration and follow-up
  • Willing and able to comply with all study assessments and protocol requirements
  • Voluntarily consents by signing the informed consent form
  • Body mass index between 18 and 32 kg/m2 inclusive, and weight at least 45 kg
  • In good physical and mental health as judged by the Investigator or delegate
Not Eligible

You will not qualify if you...

  • History of severe allergic or anaphylactic reaction
  • Pregnant, nursing, or planning pregnancy or breastfeeding during the trial
  • Known immunodeficiency disorder
  • History of cancer except non-melanoma skin cancer
  • History or positive test for HIV at screening
  • Positive laboratory evidence of active hepatitis at screening
  • Received live vaccine within 2 months before screening
  • Any condition or prior therapy that may affect safety, compliance, or study completion as judged by the Investigator or delegate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CMAX Clinical Research

Adelaide, South Australia, Australia, 5000

Actively Recruiting

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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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