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.
⁃ 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.