The primary purpose of Part A of this study is to compare, in a single dose and multiple doses the safety, tolerability, and pharmacokinetics (PK) profile administered in Japanese and Caucasian participants and of Part B of the study is to assess the food effect of a single dose of INS1007 administered in Japanese and Caucasian participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
USA001
Glendale, California, United States
Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE)
Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants.
Time frame: Up to Day 61 in Part A and up to Day 11 in Part B
Parts A and B: Area Under the Plasma Concentration-time Curve (AUC) of INS1007
Comparison of the pharmacokinetics of single and multiple doses of INS1007 in Japanese and Caucasian participants.
Time frame: Part A: Predose and at multiple time points postdose up to Day 33; Part B: Predose and at multiple time points postdose up to Day 11
Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood
Pharmacodynamic activity based on concentration of biomarkers cathepsin G (Cat G), proteinase 3 (PR3), neutrophil elastase (NE), and absolute neutrophil in blood will be assessed.
Time frame: Up to Day 61
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.