NCT07455578
尚未招募
1 期
Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease
Seismic Therapeutic AU Pty Ltd0 个研究点目标入组 24 人开始时间: 2026年2月1日最近更新:
干预措施S-4321
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Seismic Therapeutic AU Pty Ltd
- 入组人数
- 24
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Participants Major Inclusion Criteria:
- •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.
- •All Participants Major
排除标准
- •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
- •Current infection or history of severe infection
- •Any history of malignant disease, with some exceptions
- •Major inclusion/exclusion for each autoimmune or immune-mediated disease:
- •Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and:
- •≥6 swollen joint count based on 66 joint count
- •≥6 tender joint count based on 68 joint count
研究组 & 干预措施
S-4321
Experimental
Dose of S-4321
干预措施: S-4321 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Through Week 16
Incidence of serious adverse events (SAEs)
时间窗: Through Week 16
次要结局
- Change from baseline of soluble PD-1 (sPD-1)(Through Week 16)
- Incidence of anti-drug antibodies (ADAs)(Through Week 16)
- Serum concentration of S-4321(Through Week 16)
- Change from baseline in percent Receptor Occupancy (RO)(Through Week 16)
研究者
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