Healthy VolunteerPhase 1NCT06828393
A Phase 1 Study of S-1117
A Phase 1 study testing S-1117 in people with Healthy Volunteer, run by Seismic Therapeutic AU Pty Ltd at 1 site in Australia.
Trial summary
This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- S-1117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2025to Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Major Inclusion Criteria:
- 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 Criteria:
- 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 other than non-melanoma skin cancer.
- 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 received a live vaccine within 2 months of 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research
Adelaide, South Australia, 5000
CMAX Contact, 1800 150 433, cmax@cmax.com.au
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers
This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
Read the 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 will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).
- Conditions
- Healthy Volunteer
- Being tested
- S-1117, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1117Drug
S-1117 via subcutaneous or intravenous administration.
PlaceboOther
Placebo via subcutaneous or intravenous administration.
| Study group | Role | What they receive |
|---|---|---|
| S-1117 Part 1: Single ascending dose (SAD) cohorts | Experimental | Not described Receives: Drug: S-1117; Other: Placebo |
| S-1117 Part 2: Multiple ascending dose (MAD) cohorts | Experimental | Not described Receives: Drug: S-1117; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
Measured: 2 months
Secondary outcomes (9)
To assess the maximum serum concentration (CMAX)
Measured: 2 months
To assess time to reach maximum serum concentration (tMAX)
Measured: 2 months
To assess elimination half-life (t1/2)
Measured: 2 months
To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)
Measured: 2 months
To assess clearance (CL)
Measured: 2 months
To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)
Measured: 2 months
To assess bioavailability after SC administration (F%)
Measured: 2 months
To characterize absolute and proportional change from baseline of immunoglobulin G (IgG) at multiple timepoints
Measured: 2 months
Incidence and characterization of antidrug antibody (ADA)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seismic Therapeutic AU Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828393
- Sponsor's protocol ID
- S-1117-101
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06828393
- Acronym / sponsor ID
- S-1117-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Seismic Therapeutic AU Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1117 Part 1: Single ascending dose (SAD) cohorts | Experimental | Drug: S-1117, Other: Placebo |
| S-1117 Part 2: Multiple ascending dose (MAD) cohorts | Experimental | Drug: S-1117, Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1117S-1117 via subcutaneous or intravenous administration. | Drug | S-1117 Part 1: Single ascending dose (SAD) cohorts, S-1117 Part 2: Multiple ascending dose (MAD) cohorts |
| PlaceboPlacebo via subcutaneous or intravenous administration. | Other | S-1117 Part 1: Single ascending dose (SAD) cohorts, S-1117 Part 2: Multiple ascending dose (MAD) cohorts |
Primary outcome
Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
Time frame: 2 months
9 secondary outcomes
To assess the maximum serum concentration (CMAX)
Time frame: 2 months
To assess time to reach maximum serum concentration (tMAX)
Time frame: 2 months
To assess elimination half-life (t1/2)
Time frame: 2 months
To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)
Time frame: 2 months
To assess clearance (CL)
Time frame: 2 months
To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)
Time frame: 2 months
To assess bioavailability after SC administration (F%)
Time frame: 2 months
To characterize absolute and proportional change from baseline of immunoglobulin G (IgG) at multiple timepoints
Time frame: 2 months
Incidence and characterization of antidrug antibody (ADA)
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-1117 in people with Healthy Volunteer, run by Seismic Therapeutic AU Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seismic Contact (1800 244 475, clinical@seismictx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0 (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.