SAR447971 First-in-human Study

Официальное название

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

Обзор

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.

Вмешательства

• Препарат SAR447971
  Pharmaceutical form: Tablet Route of administration: Oral
• Препарат Placebo
  Pharmaceutical form: Tablet Route of administration: Oral

Первичные конечные точки

• SAD20411: Incidence of treatment emergent adverse events (TEAEs) [Срок оценки: Day 1 to Day 15]
• SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis) [Срок оценки: Day 1 to Day 15]
• SAD20411: Incidence of clinically significant abnormalities in vital signs [Срок оценки: Day 1 to Day 15]
• SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF) [Срок оценки: Day 1 to Day 15]
• MAD20412: Incidence of treatment emergent adverse events (TEAEs) [Срок оценки: Day 1 to Dat 29]
• MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis) [Срок оценки: Day 1 to Dat 29]
• MAD20412: Incidence of clinically significant abnormalities in vital signs [Срок оценки: Day 1 to Dat 29]
• MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF) [Срок оценки: Day 1 to Dat 29]
• MAD24339: Incidence of treatment emergent adverse events (TEAEs) [Срок оценки: Day 1 to Day 42]
• MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis) [Срок оценки: Day 1 to Day 42]

Вторичные конечные точки (11)

• SAD20411: PK parameter - Cmax [Срок оценки: Day 1 to Day 15]
• SAD20411: PK parameter - tmax [Срок оценки: Day 1 to Day 15]
• SAD20411:PK parameter - AUC [Срок оценки: Day 1 to Day 15]
• SAD20411: PK parameter - Cmax in fed and fasted state [Срок оценки: Day 1 to Day 15]
• SAD20411: PK parameter - tmax in fed and fasted state [Срок оценки: Day 1 to Day 15]
• SAD20411: PK parameter - AUC in fed and fasted state [Срок оценки: Day 1 to Day 15]
• MAD20412: PK parameter - Cmax [Срок оценки: Day 1 to Dat 29]
• MAD20412: PK parameter - tmax [Срок оценки: Day 1 to Dat 29]
• MAD20412: PK parameter - AUC0-tau [Срок оценки: Day 1 to Dat 29]
• MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971 [Срок оценки: Day 1 to Day 42]
• MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points [Срок оценки: Day 1 to Day 42]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Investigational Site Number: 5280001 — Leiden

Идентификаторы

NCT: NCT07629336 · SAD20411-MAD20412-MAD24339 · 2026-525333-22-00 · U1111-1334-4747

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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