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).
Adult males and females, 18 to 75 years of age (inclusive)
Body mass index (BMI) ≥18.0 and <40.0 kg/m2 with a minimum body weight of 45 kg
Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test.
Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy.
Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks
Unable or unwilling to discontinue a prohibited medication
Presence of clinically relevant immunosuppression
Single group
S-4321
DrugMultiple doses of S-4321 via subcutaneous administration
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of serious adverse events (SAEs)
Serum concentration of S-4321
Change from baseline in percent Receptor Occupancy (RO)
Change from baseline of soluble PD-1 (sPD-1)
Incidence of anti-drug antibodies (ADAs)
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Seismic Therapeutic AU Pty Ltd
Lead sponsor
Avance Clinical Pty Ltd.
Collaborator
