A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Part C and D: Change from baseline in vaccination-induced antibody titers
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
详细描述
A first-in-human Phase 1, open label study to evaluate safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
- •Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- •Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA
- •Presence of rheumatoid factor or ACPA above the ULN
- •Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment.
- •Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE
- •Positive ANA>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
- •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 the first administration of CPTX
- •- Participants diagnosed with Felty's syndrome
- •Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible)
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A: SAD Cohorts
Escalating single doses of CPTX2309 on a specified day to healthy adult participants.
干预措施: CPTX2309 (Drug)
Part B: MAD Cohorts
Escalating multiple doses of CPTX2309 on specified days to healthy adult participants.
干预措施: CPTX2309 (Drug)
Part D: MAD Cohorts
Escalating multiple doses of CPTX2309 on specified days to adult participants with moderate to severe RA or SLE.
干预措施: CPTX2309 (Drug)
Part C: SAD Cohorts
Escalating single doses of CPTX2309 on a specified day to adult participants with moderate to severe RA or SLE.
干预措施: CPTX2309 (Drug)
结局指标
主要结局
Part C and D: Change from baseline in vaccination-induced antibody titers
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to participants with moderate to severe RA and SLE.
Number of participants with changes in the safety parameters
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Number of participants with clinical laboratory assessment abnormalities
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Number of participants with changes in the vital signs
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Number of participants with changes in the ECG
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Part A and B: Number of participants with change from baseline in vaccine antibody titers
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Change from baseline in soluble immunoglobulins (Ig)
时间窗: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
次要结局
- Pharmacokinetic Parameters(Up to approximately 1 Year)
- Pharmacodynamic Parameters(Up to approximately 1 Year)
- Part A and B: Pharmacodynamic Parameters(Up to approximately 1 Year)
- Part C and D: Number of Participants who develop ADAs(Up to approximately 1 Year)