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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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Trial Transparency email recommended (Toll free for US & Canada)
- Telefoonnummer: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Studie Locaties
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Leiden, Nederland, 2333
- Werving
- Investigational Site Number: 5280001
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: SAR447971
Single or multiple doses by mouth as per protocol
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Pharmaceutical form: Tablet Route of administration: Oral
Andere namen:
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Placebo-vergelijker: Placebo
Single or multiple doses by mouth as per protocol
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Farmaceutische vorm: Tablet Toedieningsweg: Oraal
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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SAD20411: Incidence of treatment emergent adverse events (TEAEs)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Day 1 to Day 42
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Day 1 to Day 42
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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SAD20411: PK parameter - Cmax
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 1 to Day 42
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Day 1 to Day 42
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SAD20411-MAD20412-MAD24339
- 2026-525333-22-00 (Ctis)
- U1111-1334-4747 (Register-ID: ICTRP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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