NCT05140824终止1 期
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients With Systemic Lupus Erythematosus
TJ Biopharma Co., Ltd.2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of Adverse Events
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Doses of TJ202 in Patients with Systemic Lupus Erythematosus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
0.9% sodium chloride solution
干预措施: Placebo (Drug)
TJ202
Experimental
TJ202 injection
干预措施: TJ202 injection (Biological)
结局指标
主要结局
Rate of Adverse Events
时间窗: 113 days post last dose for multi- dose
Evaluate the rate of adverse events
Pharmacokinetic(PK) Parameters: Cmax
时间窗: 113 days post last dose for multi- dose
Cmax
Pharmacokinetic(PK) Parameters: Tmax
时间窗: 113 days post last dose for multi- dose
Tmax
Pharmacokinetic(PK) Parameters: AUC
时间窗: 113 days post last dose for multi- dose
AUC0-tlast
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)ALSFTDNCT04931862Wave Life Sciences Ltd.35
已完成
1 期
Study of WVE-003 in Patients With Huntington's DiseaseHuntington DiseaseNCT05032196Wave Life Sciences Ltd.47
Unknown
3 期
Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine AttacksMigraine in AdultsNCT04948164Peking University Third Hospital240
终止
3 期
Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque PsoriasisArthritis, PsoriaticNCT00090129EMD Serono854
已完成
1 期
GB004 in Adult Subjects With Active Ulcerative ColitisUlcerative ColitisNCT03860896GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.34