SAR447971 First-in-human Study
A Randomized, First-in-human, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses (SAD20411) and Multiple Ascending Doses (MAD20412) of SAR447971 With Food Effect Evaluation in Healthy Participants and of Multiple Ascending Doses (MAD24339) of SAR447971 in Patients With Hidradenitis Suppurativa
SAD20411 is a single-center, first-in-human, double-blind, randomized, placebo-controlled, sequential single ascending dose study in healthy male and/or female participants with a pilot food effect investigation.
MAD20412 is a single-center, double-blind, randomized, placebo-controlled, sequential multiple ascending dose study in healthy male and/or female participants.
MAD24339 is an open-label, sequential multiple ascending dose study in hidradenitis suppurativa (HS) male and/or female participants.
Number of participants - The total expected number of healthy participants is approximately 94 and the total number of HS participants is expected to be approximately 20.
- SAD20411 will enroll up to 46 participants
- MAD20412 will enroll up to 48 participants
- MAD24339 will enroll up to 20 participants
Duration of study - The anticipated study duration per participant is up to approximately 10 weeks in SAD20411 and MAD20412, and up to approximately 12 weeks in MAD24339.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Trial Transparency email recommended (Toll free for US & Canada)
- 电话号码:option 6 800-633-1610
- 邮箱:contact-us@sanofi.com
学习地点
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Leiden、荷兰、2333
- 招聘中
- Investigational Site Number: 5280001
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
For participation in SAD20411/MAD20412:
- Male and/or female participant, between 18 and 55 years of age, inclusive at the time of signing the ICF.
- Appearing healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
For participation in MAD24339:
- Age ≥18 and ≤65 years of age at the time of signing informed consent.
- A diagnosis of HS made by a dermatologist at least 6 months prior to baseline visit.
- HS lesions present in at least 2 distinct anatomic areas (e. g., left and right axilla; or left axilla and left inguino-crural fold), one of which must be Hurley Stage II or Hurley Stage III.
- Total AN count of ≥4 at the baseline visit. - Draining tunnel count of ≤20 at the baseline visit.
Exclusion Criteria:
For participation in SAD20411/MAD20412:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female) or signs of acute illness. Active or chronic infection requiring systemic treatment within 4 weeks prior to baseline. Known history of immunosuppression or suspected current immunosuppression.
For participation in MAD24339:
- Any active skin disease or condition other than HS (including but not limited to inflammatory skin diseases and cutaneous infections) that may interfere with assessment of HS.
- Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
- Use of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit. - Treatment with systemic antibiotics for HS within 14 days prior to the baseline visit. - Non-biologic systemic therapies with potential therapeutic impact on HS <28 days or five half-lives prior to baseline visit.
- Any history of prior treatment with any systemic biologic with a potential therapeutic impact on HS.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:SAR447971
Single or multiple doses by mouth as per protocol
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Pharmaceutical form: Tablet Route of administration: Oral
其他名称:
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安慰剂比较:Placebo
Single or multiple doses by mouth as per protocol
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药物剂型:片剂给药途径:口服
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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SAD20411: Incidence of treatment emergent adverse events (TEAEs)
大体时间:Day 1 to Day 15
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Day 1 to Day 15
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SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
大体时间:Day 1 to Day 15
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Day 1 to Day 15
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SAD20411: Incidence of clinically significant abnormalities in vital signs
大体时间:Day 1 to Day 15
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Day 1 to Day 15
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SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
大体时间:Day 1 to Day 15
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Day 1 to Day 15
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MAD20412: Incidence of treatment emergent adverse events (TEAEs)
大体时间:Day 1 to Dat 29
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Day 1 to Dat 29
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MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
大体时间:Day 1 to Dat 29
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Day 1 to Dat 29
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MAD20412: Incidence of clinically significant abnormalities in vital signs
大体时间:Day 1 to Dat 29
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Day 1 to Dat 29
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MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
大体时间:Day 1 to Dat 29
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Day 1 to Dat 29
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MAD24339: Incidence of treatment emergent adverse events (TEAEs)
大体时间:Day 1 to Day 42
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Day 1 to Day 42
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MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
大体时间:Day 1 to Day 42
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Day 1 to Day 42
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MAD24339: Incidence of clinically significant abnormalities in vital signs
大体时间:Day 1 to Day 42
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Day 1 to Day 42
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MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
大体时间:Day 1 to Day 42
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Day 1 to Day 42
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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SAD20411: PK parameter - Cmax
大体时间:Day 1 to Day 15
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Maximum serum concentration observed.
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Day 1 to Day 15
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SAD20411: PK parameter - tmax
大体时间:Day 1 to Day 15
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Time to reach Cmax.
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Day 1 to Day 15
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SAD20411:PK parameter - AUC
大体时间:Day 1 to Day 15
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Area under the plasma concentration versus time curve extrapolated to infinity.
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Day 1 to Day 15
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SAD20411: PK parameter - Cmax in fed and fasted state
大体时间:Day 1 to Day 15
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Maximum serum concentration observed.
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Day 1 to Day 15
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SAD20411: PK parameter - tmax in fed and fasted state
大体时间:Day 1 to Day 15
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Time to reach Cmax.
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Day 1 to Day 15
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SAD20411: PK parameter - AUC in fed and fasted state
大体时间:Day 1 to Day 15
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Area under the plasma concentration versus time curve extrapolated to infinity.
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Day 1 to Day 15
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MAD20412: PK parameter - Cmax
大体时间:Day 1 to Dat 29
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Maximum serum concentration observed.
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Day 1 to Dat 29
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MAD20412: PK parameter - tmax
大体时间:Day 1 to Dat 29
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Time to reach Cmax.
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Day 1 to Dat 29
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MAD20412: PK parameter - AUC0-tau
大体时间:Day 1 to Dat 29
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Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval
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Day 1 to Dat 29
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MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971
大体时间:Day 1 to Day 42
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Day 1 to Day 42
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MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points
大体时间:Day 1 to Day 42
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Day 1 to Day 42
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SAD20411-MAD20412-MAD24339
- 2026-525333-22-00 (克蒂斯)
- U1111-1334-4747 (注册表标识符:ICTRP)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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