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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Investigational Site Number: 5280001
Leiden, Netherlands
RECRUITINGSAD20411: Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Time frame: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in vital signs
Time frame: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Time frame: Day 1 to Day 15
MAD20412: Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Time frame: Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in vital signs
Time frame: Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Time frame: Day 1 to Dat 29
MAD24339: Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Time frame: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in vital signs
Time frame: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Time frame: Day 1 to Day 42
SAD20411: PK parameter - Cmax
Maximum serum concentration observed.
Time frame: Day 1 to Day 15
SAD20411: PK parameter - tmax
Time to reach Cmax.
Time frame: Day 1 to Day 15
SAD20411:PK parameter - AUC
Area under the plasma concentration versus time curve extrapolated to infinity.
Time frame: Day 1 to Day 15
SAD20411: PK parameter - Cmax in fed and fasted state
Maximum serum concentration observed.
Time frame: Day 1 to Day 15
SAD20411: PK parameter - tmax in fed and fasted state
Time to reach Cmax.
Time frame: 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.
Time frame: Day 1 to Day 15
MAD20412: PK parameter - Cmax
Maximum serum concentration observed.
Time frame: Day 1 to Dat 29
MAD20412: PK parameter - tmax
Time to reach Cmax.
Time frame: 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
Time frame: Day 1 to Dat 29
MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 to Day 42
MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points
Time frame: Day 1 to Day 42