Healthy VolunteerPhase 1NCT06877611
A Phase 1 Study of S-4321
A Phase 1 study testing S-4321 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-4321 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-4321
- 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
- 3 Apr 2025to Apr 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
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
None listed.
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
Veritus Research
Bayswater, Victoria
Veritus Contact, +61 3 8736 1750, info@veritusresearch.com
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers
This is the first-in-human study of S-4321 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, pharmacodynamics of S-4321 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-4321, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-4321Drug
S-4321 via subcutaneous or intravenous administration
PlaceboOther
Placebo via subcutaneous or intravenous administration.
| Study group | Role | What they receive |
|---|---|---|
| S-4321 Part 1: Single ascending dose (SAD) cohorts | Experimental | Not described Receives: Drug: S-4321; Other: Placebo |
| S-4321 Part 2: Multiple ascending dose (MAD) cohorts | Experimental | Not described Receives: Drug: S-4321; 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 change from baseline of Receptor Occupancy (RO) at multiple timepoints
Measured: 2 months
Incidence and characterization of anti-drug 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 Mar 2025
- Study start3 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 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
- NCT06877611
- Sponsor's protocol ID
- S-4321-101
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 15 Apr 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 15 Apr 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-4321 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06877611
- Acronym / sponsor ID
- S-4321-101
- 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
- 3 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Mar 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-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 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-4321 Part 1: Single ascending dose (SAD) cohorts | Experimental | Drug: S-4321, Other: Placebo |
| S-4321 Part 2: Multiple ascending dose (MAD) cohorts | Experimental | Drug: S-4321, Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (0 listed)
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-4321S-4321 via subcutaneous or intravenous administration | Drug | S-4321 Part 1: Single ascending dose (SAD) cohorts, S-4321 Part 2: Multiple ascending dose (MAD) cohorts |
| PlaceboPlacebo via subcutaneous or intravenous administration. | Other | S-4321 Part 1: Single ascending dose (SAD) cohorts, S-4321 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 change from baseline of Receptor Occupancy (RO) at multiple timepoints
Time frame: 2 months
Incidence and characterization of anti-drug 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 15 Apr 2025.
- Individual participant dataSharing planned: No. Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.
Related trials for Healthy Volunteer
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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-4321 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?
The sponsor lists 14 inclusion and 0 exclusion criteria. 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 15 Apr 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 15 Apr 2025.