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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Hidradenitis
• Intervention / Treatment: Drug: Placebo; Drug: SAR447971

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• Netherlands
  • Leiden, Netherlands, 2333
    • Recruiting
    • Investigational Site Number: 5280001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR447971; Single or multiple doses by mouth as per protocol	Drug: SAR447971; Pharmaceutical form: Tablet Route of administration: Oral; Other Names: KT-485
Placebo Comparator: Placebo; Single or multiple doses by mouth as per protocol	Drug: Placebo; Pharmaceutical form: Tablet Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD20411: PK parameter - Cmax	Maximum serum concentration observed.	Day 1 to Day 15
SAD20411: PK parameter - tmax	Time to reach Cmax.	Day 1 to Day 15
SAD20411:PK parameter - AUC	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	Maximum serum concentration observed.	Day 1 to Day 15
SAD20411: PK parameter - tmax in fed and fasted state	Time to reach Cmax.	Day 1 to Day 15
SAD20411: PK parameter - AUC in fed and fasted state	Area under the plasma concentration versus time curve extrapolated to infinity.	Day 1 to Day 15
MAD20412: PK parameter - Cmax	Maximum serum concentration observed.	Day 1 to Dat 29
MAD20412: PK parameter - tmax	Time to reach Cmax.	Day 1 to Dat 29
MAD20412: PK parameter - AUC0-tau	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		Day 1 to Day 42
MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points		Day 1 to Day 42

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Kymera Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): February 16, 2028
• Study Completion (Estimated): February 16, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Sweat Gland Diseases; Skin and Connective Tissue Diseases; Hidradenitis
• Other Study ID Numbers: SAD20411-MAD20412-MAD24339; 2026-525333-22-00 (Ctis); U1111-1334-4747 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No