A Phase 1 Study of S-4321

NCT06877611 | Recruiting Phase 1

• 1 other identifier: S-4321-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0

  2 months

Secondary Outcomes (9)

• To assess the maximum serum concentration (CMAX)

  2 months

• To assess time to reach maximum serum concentration (tMAX)

  2 months

• To assess elimination half-life (t1/2)

  2 months

• To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)

  2 months

• To assess clearance (CL)

  2 months

Study Arms (2)

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

Interventions

S-4321 DRUG

S-4321 via subcutaneous or intravenous administration

S-4321 Part 1: Single ascending dose (SAD) cohorts; S-4321 Part 2: Multiple ascending dose (MAD) cohorts

Placebo OTHER

Placebo via subcutaneous or intravenous administration.

S-4321 Part 1: Single ascending dose (SAD) cohorts; S-4321 Part 2: Multiple ascending dose (MAD) cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seismic Therapeutic AU Pty Ltd: lead
• Avance Clinical Pty Ltd.: collaborator

Study Sites (1)

Veritus Research

Bayswater, Victoria, Australia

RECRUITING

Central Study Contacts

Seismic Contact

CONTACT

1800 244 475; clinical@seismictx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)