Healthy Volunteers, Hidradenitis
Conditions
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.
Interventions
DRUGSAR447971
Pharmaceutical form: Tablet Route of administration: Oral
DRUGPlacebo
Pharmaceutical form: Tablet Route of administration: Oral
Sponsors
Sanofi
Kymera Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| SAD20411: PK parameter - Cmax | Day 1 to Day 15 | Maximum serum concentration observed. |
| SAD20411: PK parameter - tmax | Day 1 to Day 15 | Time to reach Cmax. |
| SAD20411:PK parameter - AUC | Day 1 to Day 15 | Area under the plasma concentration versus time curve extrapolated to infinity. |
| SAD20411: PK parameter - Cmax in fed and fasted state | Day 1 to Day 15 | Maximum serum concentration observed. |
| SAD20411: PK parameter - tmax in fed and fasted state | Day 1 to Day 15 | Time to reach Cmax. |
| SAD20411: PK parameter - AUC in fed and fasted state | Day 1 to Day 15 | Area under the plasma concentration versus time curve extrapolated to infinity. |
| MAD20412: PK parameter - Cmax | Day 1 to Dat 29 | Maximum serum concentration observed. |
| MAD20412: PK parameter - tmax | Day 1 to Dat 29 | Time to reach Cmax. |
| MAD20412: PK parameter - AUC0-tau | Day 1 to Dat 29 | Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval |
| 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 | — |
Countries
Netherlands
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed