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

Recruiting Phase 1 Interventional Study
Autoimmune Diseases Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA) Psoriasis (PsO) Cutaneous Lupus Erythematosus (CLE) Atopic Dermatitis (AD)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Seismic Therapeutic AU Pty Ltd · Industry
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About This Trial
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 w…
Trial Locations
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Eligibility Criteria
All Participants Major Inclusion Criteria: 1. Adult males and females, 18 to 75 years of age (inclusive) 2. Body mass index (BMI) ≥18.0 and \<40.0 kg/m2 with a minimum body weight of 45 kg 3. Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing pote…
Contacts

Seismic Contact

1800 244 475

clinical@seismictx.com

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