Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease

Sponsor
Seismic Therapeutic AU Pty Ltd
Study ID
NCT07455578
Phase
PHASE1
Status
Recruiting
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Conditions

  • Atopic Dermatitis (AD)
  • Autoimmune Diseases
  • Cutaneous Lupus Erythematosus (CLE)
  • Psoriasis (PsO)
  • Psoriatic Arthritis (PsA)
  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • S-4321 — DRUG
    Multiple doses of S-4321 via subcutaneous administration

Study Details

This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).

Key Dates

First listed
Mar 6, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: S-4321
    SC Dose of S-4321

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through Week 31 ]

Central Contacts

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