Trials / Not Yet Recruiting
Not Yet RecruitingNCT07455578
Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease
Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Seismic Therapeutic AU Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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 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).
Conditions
- Autoimmune Diseases
- Rheumatoid Arthritis (RA)
- Psoriatic Arthritis (PsA)
- Psoriasis (PsO)
- Cutaneous Lupus Erythematosus (CLE)
- Atopic Dermatitis (AD)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S-4321 | S-4321 via subcutaneous administration |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2026-03-06
- Last updated
- 2026-03-06
Source: ClinicalTrials.gov record NCT07455578. Inclusion in this directory is not an endorsement.