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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Trial Transparency email recommended (Toll free for US & Canada)
- 電話番号:option 6 800-633-1610
- メール:contact-us@sanofi.com
研究場所
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Leiden、オランダ、2333
- 募集
- Investigational Site Number: 5280001
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:順次割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:SAR447971
Single or multiple doses by mouth as per protocol
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Pharmaceutical form: Tablet Route of administration: Oral
他の名前:
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プラセボコンパレーター:Placebo
Single or multiple doses by mouth as per protocol
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剤形:錠剤 投与経路:経口
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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SAD20411: Incidence of treatment emergent adverse events (TEAEs)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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)
時間枠:Day 1 to Day 42
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Day 1 to Day 42
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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SAD20411: PK parameter - Cmax
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Day 1 to Day 42
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Day 1 to Day 42
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SAD20411-MAD20412-MAD24339
- 2026-525333-22-00 (Ctis)
- U1111-1334-4747 (レジストリ識別子:ICTRP)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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