The purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
94
Investigator Site
Harrow, United Kingdom
Number of subjects with TEAEs and number of events will be summarised by treatment
Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion
Time frame: 21 days
Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.
Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Time frame: 14 days
Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Time frame: 14 days
Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.
RR-interval, PR (PQ)-interval, QRS-duration, QT-interval, QTcB, QTcF and heart rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Time frame: 14 days
Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.
Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14.
Time frame: 14 days
Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
PK of PIN201104: The time to reach Cmax (Tmax)
Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)
t1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)
AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)
CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
PK of PIN201104: Apparent volume of distribution (Vz/F)
Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours