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Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2026-05-26
Completion Date
2028-02-16
Last Updated
2026-06-05
Healthy Volunteers
Yes
Conditions
Interventions
SAR447971
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Locations (1)
Investigational Site Number: 5280001
Leiden, Netherlands