NCT07284797招募中1 期
A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Xencor, Inc.
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.
详细描述
This is a Phase 1 study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb657 in healthy adult participants and participants with autoimmune diseases.
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
- 是
入选标准
- •Healthy participants - Adult participants in good health
- •Idiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) Classification Criterion for IIM
- •Systemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR/EULAR Classification Criteria for SSc
- •Sjogren's Disease participants that meet the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
- •All participants - Use of highly effective methods of contraception
排除标准
- •Major surgery within 12 weeks prior to dosing or planned within the study
- •Recurrent infections or active clinically significant infection
- •Active or untreated latent tuberculosis
- •Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
- •Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- •Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.
研究组 & 干预措施
Dose Escalation
Experimental
XmAb657 administered SC
干预措施: XmAb657 (Biological)
结局指标
主要结局
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Through Week 52
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Through Week 24
次要结局
- Serum concentration of XmAb657(Through Week 52)
- Serum concentration of XmAb657(Through Week 24)
研究者
研究点 (2)
Loading locations...
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