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RECRUITING
NCT07629336
PHASE1

SAR447971 First-in-human Study

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Interventions

DRUG

SAR447971

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Locations (1)

Investigational Site Number: 5280001

Leiden, Netherlands