This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Hadassah Ein Kerem Hospital Clinical Research Center
Jerusalem, Israel
Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)
Incidence, nature, and severity of AEs and SAEs
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
Time frame: Day 1 through Day 31
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Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
using an ECG machine that automatically calculates heart rate and measure PR, QRS, QT, and QTc intervals
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal Pulmonary function tests results
Pulmonary function tests will be performed according to the ATS/ERS and FEV1, FVC, and FEF25-75 will be measured
Time frame: Day 1 through Day 31
Characterization of PK of SPL84: maximum serum concentration (Cmax)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Time to Cmax (Tmax)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: terminal elimination half-life (t1/2)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Apparent clearance (CL/F)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.