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SAR447971 First-in-human Study

2026年6月4日 更新者:Sanofi

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

介入性

注册 (估计的)

114

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

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

      • Leiden、荷兰、2333
        • 招聘中
        • Investigational Site Number: 5280001

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:SAR447971
Single or multiple doses by mouth as per protocol
Pharmaceutical form: Tablet Route of administration: Oral
其他名称:
  • KT-485
安慰剂比较:Placebo
Single or multiple doses by mouth as per protocol
药物剂型:片剂给药途径:口服

研究衡量的是什么?

主要结果指标

结果测量
大体时间
SAD20411: Incidence of treatment emergent adverse events (TEAEs)
大体时间:Day 1 to Day 15
Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
大体时间:Day 1 to Day 15
Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in vital signs
大体时间:Day 1 to Day 15
Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
大体时间:Day 1 to Day 15
Day 1 to Day 15
MAD20412: Incidence of treatment emergent adverse events (TEAEs)
大体时间:Day 1 to Dat 29
Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
大体时间:Day 1 to Dat 29
Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in vital signs
大体时间:Day 1 to Dat 29
Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
大体时间:Day 1 to Dat 29
Day 1 to Dat 29
MAD24339: Incidence of treatment emergent adverse events (TEAEs)
大体时间:Day 1 to Day 42
Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
大体时间:Day 1 to Day 42
Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in vital signs
大体时间:Day 1 to Day 42
Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
大体时间:Day 1 to Day 42
Day 1 to Day 42

次要结果测量

结果测量
措施说明
大体时间
SAD20411: PK parameter - Cmax
大体时间:Day 1 to Day 15
Maximum serum concentration observed.
Day 1 to Day 15
SAD20411: PK parameter - tmax
大体时间:Day 1 to Day 15
Time to reach Cmax.
Day 1 to Day 15
SAD20411:PK parameter - AUC
大体时间:Day 1 to Day 15
Area under the plasma concentration versus time curve extrapolated to infinity.
Day 1 to Day 15
SAD20411: PK parameter - Cmax in fed and fasted state
大体时间:Day 1 to Day 15
Maximum serum concentration observed.
Day 1 to Day 15
SAD20411: PK parameter - tmax in fed and fasted state
大体时间:Day 1 to Day 15
Time to reach Cmax.
Day 1 to Day 15
SAD20411: PK parameter - AUC in fed and fasted state
大体时间:Day 1 to Day 15
Area under the plasma concentration versus time curve extrapolated to infinity.
Day 1 to Day 15
MAD20412: PK parameter - Cmax
大体时间:Day 1 to Dat 29
Maximum serum concentration observed.
Day 1 to Dat 29
MAD20412: PK parameter - tmax
大体时间:Day 1 to Dat 29
Time to reach Cmax.
Day 1 to Dat 29
MAD20412: PK parameter - AUC0-tau
大体时间:Day 1 to Dat 29
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval
Day 1 to Dat 29
MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971
大体时间:Day 1 to Day 42
Day 1 to Day 42
MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points
大体时间:Day 1 to Day 42
Day 1 to Day 42

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月26日

初级完成 (估计的)

2028年2月16日

研究完成 (估计的)

2028年2月16日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

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)?

是的

IPD 计划说明

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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