NCT06143371已完成1 期
A Phase I (First-in-human) Randomized, Double-blind, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CAN10, an Anti-IL1RAP Monoclonal Antibody, in Healthy Subjects and in Subjects With Mild to Moderate Plaque Psoriasis.
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年8月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of single and multiple ascending doses of CAN10
研究概览
简要总结
This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body. In the first part of the study, the single ascending dose (SAD) cohorts, CAN10 will be given as a single intravenous dose to healthy subjects. In the second part of the study, the multiple ascending dose (MAD) cohorts, CAN10 will be given as repeated subcutaneous doses to participants with mild to moderate plaque psoriasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
- •Body mass index (BMI) 18 to 30 kg/m2 (inclusive) and a weight between 50 to 100 kg (inclusive) at the time of screening
- •Considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- •Female subjects of childbearing potential must use a highly effective method of birth control and have a negative pregnancy test at screening and before the first dose of study drug. Male subjects with female partners must agree to use a condom, and their female partners are recommended to use a highly effective method of birth control.
- •Additionally for subjects with plaque psoriasis only:
- •A diagnosis of plaque psoriasis with Psoriasis Area Severity Index (PASI) score ≥3 to ≤15 and Physician Global Assessment (PGA) score ≥2 (mild) to <4 (moderate).
- •No disease manifestation requiring systemic immunosuppressive therapy.
排除标准
- •History or presence of:
- •Severe allergy/hypersensitivity (subjects with mild pollen allergy can be included).
- •Significant kidney, liver, or urologic disease.
- •Clinically significant psychiatric disorders
- •Tuberculosis (TB) infection or positive QuantiFERON TB Gold test
- •Any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- •Clinically significant illness, medical/surgical procedure, or trauma within 4 weeks before the first dose of study drug.
- •Ongoing opportunistic or systemic infections
- •A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibodies at screening.
- •Additionally for subjects with plaque psoriasis only:
- •Psoriasis other than a plaque variant.
- •Any sign of infection of any of the psoriatic lesions.
- •Use of any of the following treatments within the indicated washout period before the first dose of study drug:
- •12 weeks or 5 half-lives (whichever is longer) for biologic agents known or expected to impact the course of psoriasis or its assessments.
- •12 weeks for oral retinoids
- •8 weeks for cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
- •2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless on a stable dose for >12 weeks
- •1 week for topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body)
研究组 & 干预措施
CAN10 single ascending dose
Experimental
A single dose of CAN10 will be administered intravenously (IV) to healthy subjects.
干预措施: CAN10 (Biological)
CAN10 single ascending dose - placebo
Placebo Comparator
A single dose of matching placebo will be administered intravenously (IV) to healthy subjects.
干预措施: CAN10 - Placebo (Biological)
CAN10 multiple ascending dose
Experimental
Multiple doses of CAN10 will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis
干预措施: CAN10 (Biological)
CAN10 multiple ascending dose - placebo
Placebo Comparator
Multiple doses of matching placebo will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis
干预措施: CAN10 - Placebo (Biological)
结局指标
主要结局
To investigate the safety and tolerability of single and multiple ascending doses of CAN10
时间窗: From the day of the first dose until day 57 after the last dose
Frequency, seriousness, and intensity of treatment-emergent adverse events (TEAEs) in subjects receiving single and multiple doses of CAN10
次要结局
- Assessment of the maximum observed concentration (Cmax) following single (IV) and multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
- Assessment of Area under plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) after single (IV) dosing(From the day of dosing (day 1) until day 57 after dosing)
- Assessment of time to maximum observed serum concentration (Tmax) following single (IV) and multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
- Assessment of the terminal elimination rate constant (λz) following single (IV) and multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
- Assessment of the volume of distribution (Vd) following single (IV) dosing(From the day of dosing (day 1) until day 57 after dosing)
- Assessment of volume of distribution following extravascular administration (Vd/F) following multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
- Assessment of AUC from time zero to last measurable serum concentration (AUClast) following single (IV) and multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
- Assessment of AUC from time 0 to 336 hours post dose (i.e., AUC over a 2-week interval) after multiple (SC) dosing on Day 36 (AUC0-336,MD)(From the last dose until 336 hours after the last dose)
- Assessment of the total clearance (CL) following single (IV) dosing)(From the day of dosing (day 1) until day 57 after dosing)
- Assessment of total clearance following extravascular administration (CL/F) following multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
- Assessment of the terminal halflife (t1/2) following single (IV) and multiple (SC) dosing(From the day of the first dose until day 57 after the last dose)
研究者
研究点 (1)
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