This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
116
Randomised, double-blinded, placebo-controlled
Covance Clinical Research Unit (CRU) Ltd.
Leeds, United Kingdom
Incidence and severity of any drug-related adverse events
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Time frame: Up to 21 days
Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs
Time frame: Up to 21 days
Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests
Time frame: Up to 21 days
Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF])
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG
Time frame: Up to 21 days
Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria)
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG
Time frame: Up to 21 days
Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])
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To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests
Time frame: Up to 21 days
Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments
Time frame: Up to 21 days
Number of subjects with abnormal physical examinations
To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations
Time frame: Up to 21 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 21 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 21 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 21 days
Apparent plasma terminal elimination half-life (T1/2)
Time frame: Up to 21 days
The lowest absolute value of lymphocytes at postdose (nadir)
Time frame: Up to 21 days
The lowest percentage of baseline (nadir [%])
Time frame: Up to 21 days
Time of nadir (Tnadir)
Time frame: Up to 21 days
Area under the effectiveness curve (AUCE)
Time frame: Up to 21 days