Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06877611




Registration number
NCT06877611
Ethics application status
Date submitted
10/03/2025
Date registered
14/03/2025
Date last updated
15/04/2025

Titles & IDs
Public title
A Phase 1 Study of S-4321
Scientific title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers
Secondary ID [1] 0 0
S-4321-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - S-4321
Other interventions - Placebo

Experimental: S-4321 Part 1: Single ascending dose (SAD) cohorts -

Experimental: S-4321 Part 2: Multiple ascending dose (MAD) cohorts -


Treatment: Drugs: S-4321
S-4321 via subcutaneous or intravenous administration

Other interventions: Placebo
Placebo via subcutaneous or intravenous administration.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
Timepoint [1] 0 0
2 months
Secondary outcome [1] 0 0
To assess the maximum serum concentration (CMAX)
Timepoint [1] 0 0
2 months
Secondary outcome [2] 0 0
To assess time to reach maximum serum concentration (tMAX)
Timepoint [2] 0 0
2 months
Secondary outcome [3] 0 0
To assess elimination half-life (t1/2)
Timepoint [3] 0 0
2 months
Secondary outcome [4] 0 0
To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)
Timepoint [4] 0 0
2 months
Secondary outcome [5] 0 0
To assess clearance (CL)
Timepoint [5] 0 0
2 months
Secondary outcome [6] 0 0
To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)
Timepoint [6] 0 0
2 months
Secondary outcome [7] 0 0
To assess bioavailability after SC administration (F%)
Timepoint [7] 0 0
2 months
Secondary outcome [8] 0 0
To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints
Timepoint [8] 0 0
2 months
Secondary outcome [9] 0 0
Incidence and characterization of anti-drug antibody (ADA)
Timepoint [9] 0 0
2 months

Eligibility
Key inclusion criteria
1. Is available for the entire duration of the study and follow up.
2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
4. Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs =45 kg.
5. Is in good physical and mental health in the opinion of the Investigator or delegate.

Major
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
3. Has a known immunodeficiency disorder.
4. Has a history of malignancy or confirmed cervical dysplasia.
5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
6. Has positive laboratory evidence for active hepatitis at screening.
7. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Veritus Research - Bayswater
Recruitment postcode(s) [1] 0 0
- Bayswater

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seismic Therapeutic AU Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seismic Contact
Address 0 0
Country 0 0
Phone 0 0
1800 244 475
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06877611