A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE201 Administered Subcutaneously in Participants With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis
研究概览
简要总结
This is a Phase 1, first in human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to placebo in participants with Rheumatoid Arthritis
详细描述
This is a multisite, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE201 in participants with Rheumatoid Arthritis. Approximately 36 evaluable participants (6 in each cohort) will be enrolled. JADE201 will be administered by a subcutaneous injection. The results of this study will form the foundation for subsequent clinical development of JADE201 in autoimmune indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants 18-70 years of age, inclusive.
- •A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening.
- •Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria
- •Willing and able to comply with the inpatient stay at the site, scheduled visits, treatment plans, laboratory tests, and other study procedures specified in the protocol.
- •Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol.
排除标准
- •With the exception of RA, known history of clinically significant disease
- •Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA
- •positive serology for Hep A, Hep B, or Hep C virus
- •Positive, indeterminate, or invalid test of TB
- •Current tobacco users who smoke >5 cigarettes per day or equivalent
- •Nursing, lactating or pregnant, or who have plans to become pregnant during the study
- •Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration
研究组 & 干预措施
JADE201
Subcutaneous (SC) injection of JADE201
干预措施: JADE201 (Drug)
Placebo
Subcutaneous (SC) injection of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis
时间窗: Day 1 through 36 weeks
Incidence of treatment-emergent adverse events
次要结局
- Cmax(Day 1 through Weeek 36)
- Tmax(Day 1 through Week 36)
- AUClast(Day 1 through Week 36)
- T1/2(Day 1 through Week 36)