Actively Recruiting
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers
Led by Seismic Therapeutic AU Pty Ltd · Updated on 2025-03-12
96
Participants Needed
1
Research Sites
N/A
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
Researchers are conducting a first-in-human, phase 1 clinical trial to study S-1117, a drug being tested in healthy adult volunteers. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-1117. It is a randomized, placebo-controlled, double-blind trial sponsored by Seismic Therapeutic AU Pty Ltd, designed to collect important data on how the drug behaves in the human body. The trial is divided into two parts: Part 1 involves single ascending doses (SAD) of S-1117, and Part 2 involves multiple ascending doses (MAD). Both S-1117 and placebo are administered either subcutaneously or intravenously. Participants will receive varying doses to help assess how the drug is processed and tolerated over time. Participants will be monitored closely with assessments over approximately two months, including tracking any treatment-related adverse events. Researchers will measure drug levels in the blood, including maximum concentration, time to reach peak levels, elimination half-life, clearance, volume of distribution, and bioavailability. Immunologic responses, such as changes in immunoglobulin G and the development of antidrug antibodies, will also be evaluated. The study includes regular safety monitoring and follow-up to ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
A Phase 1 Study of S-1117
Who Can Participate
Eligibility Criteria
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 schedule
- Provides voluntary informed consent
- Body mass index (BMI) between 18 and 32 kg/m2 and weight at least 45 kg
- In good physical and mental health as determined by the investigator
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 malignancy other than 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 other condition or prior therapy that may compromise safety, compliance, or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 months
Participants receive a single ascending dose of S-1117 or placebo to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits during dosing and monitoring
Duration - Up to 2 months
Participants receive multiple ascending doses of S-1117 or placebo to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits during dosing and monitoring
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
S
Seismic 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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