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SAR447971 First-in-human Study

4 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Studietyp

Interventionell

Inskrivning (Beräknad)

114

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-post: contact-us@sanofi.com

Studieorter

      • Leiden, Nederländerna, 2333
        • Rekrytering
        • Investigational Site Number: 5280001

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: SAR447971
Single or multiple doses by mouth as per protocol
Pharmaceutical form: Tablet Route of administration: Oral
Andra namn:
  • KT-485
Placebo-jämförare: Placebo
Single or multiple doses by mouth as per protocol
Läkemedelsform: Tablett Administreringssätt: Oral

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SAD20411: PK parameter - Cmax
Tidsram: Day 1 to Day 15
Maximum serum concentration observed.
Day 1 to Day 15
SAD20411: PK parameter - tmax
Tidsram: Day 1 to Day 15
Time to reach Cmax.
Day 1 to Day 15
SAD20411:PK parameter - AUC
Tidsram: 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
Tidsram: Day 1 to Day 15
Maximum serum concentration observed.
Day 1 to Day 15
SAD20411: PK parameter - tmax in fed and fasted state
Tidsram: Day 1 to Day 15
Time to reach Cmax.
Day 1 to Day 15
SAD20411: PK parameter - AUC in fed and fasted state
Tidsram: 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
Tidsram: Day 1 to Dat 29
Maximum serum concentration observed.
Day 1 to Dat 29
MAD20412: PK parameter - tmax
Tidsram: Day 1 to Dat 29
Time to reach Cmax.
Day 1 to Dat 29
MAD20412: PK parameter - AUC0-tau
Tidsram: 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
Tidsram: Day 1 to Day 42
Day 1 to Day 42
MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points
Tidsram: Day 1 to Day 42
Day 1 to Day 42

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Samarbetspartners

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 maj 2026

Primärt slutförande (Beräknad)

16 februari 2028

Avslutad studie (Beräknad)

16 februari 2028

Studieregistreringsdatum

Först inskickad

22 maj 2026

Först inskickad som uppfyllde QC-kriterierna

4 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • SAD20411-MAD20412-MAD24339
  • 2026-525333-22-00 (Ctis)
  • U1111-1334-4747 (Registeridentifierare: ICTRP)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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