NCT07291323招募中1 期
A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of JANX011 With Optional Step-Up Dosing in Healthy Adult Volunteers
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.
研究概览
简要总结
This first-in-human (FIH) study aims to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JANX011 dosed subcutaneously (and potentially intravenously) in healthy adult volunteers (HVs) to gain insight into its therapeutic utility in patients with autoimmune diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, in the opinion of the PI or designee and as determined by physical examination, laboratory screening tests, and medical history.
- •Aged 18 to 65 years, with a body weight between 50 to 120 kg and a body mass index (BMI) between 18 to 32 kg/m2 (all inclusive) at Screening.
- •Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
排除标准
- •Recent surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.
- •Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus 1 (HIV-1) or HIV-2 antibodies.
- •Positive test for tuberculosis (TB) or history of TB (including prior positive interferon gold test result).
- •Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to dosing on Day 1.
研究组 & 干预措施
Dose Escalation
Experimental
Dosage per cohort will increase to determine the maximum tolerable dose.
干预措施: JANX011 (Drug)
结局指标
主要结局
Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.
时间窗: Up to 85 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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