- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07629336
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Trial Transparency email recommended (Toll free for US & Canada)
- Numero di telefono: option 6 800-633-1610
- Email: contact-us@sanofi.com
Luoghi di studio
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Leiden, Olanda, 2333
- Reclutamento
- Investigational Site Number: 5280001
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: SAR447971
Single or multiple doses by mouth as per protocol
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Pharmaceutical form: Tablet Route of administration: Oral
Altri nomi:
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Comparatore placebo: Placebo
Single or multiple doses by mouth as per protocol
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Forma farmaceutica: compresse Via di somministrazione: orale
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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SAD20411: Incidence of treatment emergent adverse events (TEAEs)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Day 1 to Day 15
|
Day 1 to Day 15
|
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SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Lasso di tempo: Day 1 to Day 15
|
Day 1 to Day 15
|
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MAD20412: Incidence of treatment emergent adverse events (TEAEs)
Lasso di tempo: 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)
Lasso di tempo: Day 1 to Dat 29
|
Day 1 to Dat 29
|
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MAD20412: Incidence of clinically significant abnormalities in vital signs
Lasso di tempo: 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)
Lasso di tempo: Day 1 to Dat 29
|
Day 1 to Dat 29
|
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MAD24339: Incidence of treatment emergent adverse events (TEAEs)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Day 1 to Day 42
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Day 1 to Day 42
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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SAD20411: PK parameter - Cmax
Lasso di tempo: 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
Lasso di tempo: Day 1 to Day 15
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Time to reach Cmax.
|
Day 1 to Day 15
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SAD20411:PK parameter - AUC
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 1 to Day 15
|
Time to reach Cmax.
|
Day 1 to Day 15
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SAD20411: PK parameter - AUC in fed and fasted state
Lasso di tempo: Day 1 to Day 15
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Area under the plasma concentration versus time curve extrapolated to infinity.
|
Day 1 to Day 15
|
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MAD20412: PK parameter - Cmax
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 1 to Day 42
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Day 1 to Day 42
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SAD20411-MAD20412-MAD24339
- 2026-525333-22-00 (Ctis)
- U1111-1334-4747 (Identificatore di registro: ICTRP)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .