NCT07732309尚未招募1 期
A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 149
- 试验地点
- 22
- 主要终点
- Safety and TolerabilitySafety and Tolerability
研究概览
简要总结
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
详细描述
This is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who give consent to this study participation and sign informed consent form.
- •Participants at least 18 years of age inclusive at screening visit.
- •Must be able to adhere to the study visit schedule and other protocol .requirements.
- •Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.
- •Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.
- •SLE: subjects:
- •Have a confirmed diagnosis of SLE and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria at screening.
- •Have active SLE disease.
- •Have had previous treatment failure.
排除标准
- •Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).
- •Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.
- •Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.
- •Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.
- •Uncontrolled other diseases: history or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
- •History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant.
- •Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study.
- •Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (>60 mg/day) within 2 months prior to screening.
- •Live or attenuated vaccine within 28 days prior to screening or during screening.
- •Participants who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.
- •The participant has an abnormality on 12-lead electrocardiogram at screening which is clinically significant in the opinion of the investigator, and which could confound the results of the study.
结局指标
主要结局
Safety and TolerabilitySafety and Tolerability
时间窗: 48 weeks
Incidence and severity of adverse events (AEs), CRS.
次要结局
未报告次要终点
研究者
研究点 (22)
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