A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Patients With Primary Sjogren's Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of adverse events and serious adverse events
研究概览
简要总结
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Understand and sign the informed consent form;
- •Age ≥ 18 years, male or female；
- •Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m² (inclusive);
- •Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for Sjögren's Syndrome;
- •Positive for anti-Sjögren's syndrome A autoantibodies (SSA) and/or anti-Sjögren's syndrome B autoantibodies (SSB);
- •Unstimulated whole salivary flow rate > 0 ml/min;
排除标准
- •Individuals who have had allergic reactions to any components of IBI355, have allergic diseases, or possess an allergic constitution;
- •Those who cannot tolerate frequent venipuncture procedures;
- •Participants diagnosed with secondary Sjögren's syndrome, or whose clinical symptoms (or laboratory abnormalities) require explanation by another connective tissue disease (such as systemic lupus erythematosus, mixed connective tissue disease, etc.).
- •Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
- •Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
- •HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
- •There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
- •6.Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
- •Subject with a hcg positive; 8.Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial; 9.Patients with pulmonary interstitial fibrosis, or those requiring combined antifibrotic drug therapy, or those with abnormal lung function that the investigators determined was not suitable for this study;
- •Need to use other drugs that could cause xerostomia during the study.
研究组 & 干预措施
IBI355 30mg/kg
IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (8:2)
干预措施: IBI355 placebo (Drug)
IBI355 7.5mg/kg
IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (8:2)
干预措施: IBI355 (Drug)
IBI355 7.5mg/kg
IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (8:2)
干预措施: IBI355 placebo (Drug)
IBI355 15mg/kg
IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (8:2)
干预措施: IBI355 (Drug)
IBI355 15mg/kg
IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (8:2)
干预措施: IBI355 placebo (Drug)
IBI355 30mg/kg
IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (8:2)
干预措施: IBI355 (Drug)
结局指标
主要结局
Incidence of adverse events and serious adverse events
时间窗: up to week 24
次要结局
- Area under the Curve(AUC) of multi-dose of IBI355(Up to week 16)
- Peak serum concentration(Cmax) of multi-dose of IBI355(Up to week 16)
- Clearance (CL) of multi-dose of IBI355(Up to week 16)
- Half-life (t1/2) of multi-dose of IBI355(Up to week 16)
- The ratio of Anti-drug antibody of multi-dose of IBI355(Up to week 24)