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NCT Number: NCT07629336

SAR447971 First-in-human Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number: 5280001

Leiden, 2333, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR447971

Drug

Pharmaceutical form: Tablet Route of administration: Oral

Other names: KT-485

Placebo

Drug

Pharmaceutical form: Tablet Route of administration: Oral

Primary outcomes

  1. SAD20411: Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 15

  2. SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)

    Time frame: Day 1 to Day 15

  3. SAD20411: Incidence of clinically significant abnormalities in vital signs

    Time frame: Day 1 to Day 15

  4. SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)

    Time frame: Day 1 to Day 15

  5. MAD20412: Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Dat 29

  6. MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)

    Time frame: Day 1 to Dat 29

  7. MAD20412: Incidence of clinically significant abnormalities in vital signs

    Time frame: Day 1 to Dat 29

  8. MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)

    Time frame: Day 1 to Dat 29

  9. MAD24339: Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 42

  10. MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)

    Time frame: Day 1 to Day 42

  11. MAD24339: Incidence of clinically significant abnormalities in vital signs

    Time frame: Day 1 to Day 42

  12. MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)

    Time frame: Day 1 to Day 42

Secondary outcomes

  1. SAD20411: PK parameter - Cmax

    Time frame: Day 1 to Day 15

    Maximum serum concentration observed.

  2. SAD20411: PK parameter - tmax

    Time frame: Day 1 to Day 15

    Time to reach Cmax.

  3. SAD20411:PK parameter - AUC

    Time frame: Day 1 to Day 15

    Area under the plasma concentration versus time curve extrapolated to infinity.

  4. SAD20411: PK parameter - Cmax in fed and fasted state

    Time frame: Day 1 to Day 15

    Maximum serum concentration observed.

  5. SAD20411: PK parameter - tmax in fed and fasted state

    Time frame: Day 1 to Day 15

    Time to reach Cmax.

  6. SAD20411: PK parameter - AUC in fed and fasted state

    Time frame: Day 1 to Day 15

    Area under the plasma concentration versus time curve extrapolated to infinity.

  7. MAD20412: PK parameter - Cmax

    Time frame: Day 1 to Dat 29

    Maximum serum concentration observed.

  8. MAD20412: PK parameter - tmax

    Time frame: Day 1 to Dat 29

    Time to reach Cmax.

  9. MAD20412: PK parameter - AUC0-tau

    Time frame: Day 1 to Dat 29

    Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval

  10. MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971

    Time frame: Day 1 to Day 42

  11. MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points

    Time frame: Day 1 to Day 42

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Kymera Therapeutics, Inc.

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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