SAR447971 First-in-human Study

NCT07629336 | Recruiting Phase 1

• 3 other identifiers: SAD20411-MAD20412-MAD243392026-525333-22-00U1111-1334-4747
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Hidradenitis

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (11)

• SAD20411: PK parameter - Cmax

  Day 1 to Day 15

• SAD20411: PK parameter - tmax

  Day 1 to Day 15

• SAD20411:PK parameter - AUC

  Day 1 to Day 15

• SAD20411: PK parameter - Cmax in fed and fasted state

  Day 1 to Day 15

• SAD20411: PK parameter - tmax in fed and fasted state

  Day 1 to Day 15

Study Arms (2)

SAR447971

EXPERIMENTAL

Single or multiple doses by mouth as per protocol

Drug: SAR447971

Placebo

PLACEBO COMPARATOR

Single or multiple doses by mouth as per protocol

Drug: Placebo

Interventions

SAR447971 DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Also known as: KT-485

SAR447971

Placebo DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Kymera Therapeutics, Inc.: collaborator

Study Sites (1)

Investigational Site Number: 5280001

Leiden, 2333, Netherlands

RECRUITING

MeSH Terms

Conditions

Hidradenitis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 5, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): February 16, 2028
• Study Completion (Estimated): February 16, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)