A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
- 试验地点
- 17
- 主要终点
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
详细描述
This is an open-label, uncontrolled study in participants with RA. PIT565 will be administered subcutaneously. The objective of the study is to assess the safety of PIT565 in participants with RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study. Male and female patients, aged 18 to 75 years at screening, diagnosed with RA according to the 2010 ACR/EULAR or 1987 ACR classification at least 12 weeks prior to screening.
- •Immunization (primary or from vaccinations) against pneumococcus, influenza, meningococcus and COVID-19 infection at least 2 weeks prior to the first dosing. Local guidelines should be followed to determine requirement for vaccination (or booster), as well as the type and schedule of vaccination.
排除标准
- •Any of the following cardiac conditions
- •Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening
- •Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2) or uncontrolled hypertension
- •Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block without a pacemaker
- •History of familial long QT syndrome or known family history of Torsades-de- Pointes
- •Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening
- •Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
PIT565 dose 1
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 2
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 3
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 4
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 8
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 7
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 6
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
PIT565 dose 5
Study treatment will be provided in vials as open-label participant specific supply.
干预措施: PIT565 (Biological)
结局指标
主要结局
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 6 months
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
次要结局
- Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax](up to 6 months)
- Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC)(up to 6 months)
- Concentrations of anti-PIT565 antibodies(Baseline, up to 6 months)