A Randomised, First-in-human, Double-blinded, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CP1050 in Healthy Subjects; Including the Effect of Food and Gender on the Pharmacokinetics and Pharmacodynamics of a Single Dose of CP1050 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- CP1050 or Placebo
- Conditions
- Healthy Subjects
- Sponsor
- Curadim Pharma Co., Ltd.
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- 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])
- Last Updated
- 8 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Caucasian males or females between 18 and 55 years of age (inclusive).
- •A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
- •Healthy and free from clinically significant illness or disease.
Exclusion Criteria
- •Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
- •Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
- •Clinically significant abnormalities in ECG or laboratory tests.
Arms & Interventions
Single ascending dose, CP1050 or Placebo
Intervention: CP1050 or Placebo
Multiple ascending dose, CP1050 or Placebo
Intervention: CP1050 or Placebo
Outcomes
Primary Outcomes
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])
Time Frame: Up to 21 days
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
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)
Time Frame: Up to 21 days
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
Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)
Time Frame: Up to 21 days
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
Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT
Time Frame: Up to 21 days
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
Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])
Time Frame: Up to 21 days
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
Number of subjects with abnormal physical examinations
Time Frame: Up to 21 days
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
Incidence and severity of any drug-related adverse events
Time Frame: Up to 21 days
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
Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)
Time Frame: Up to 21 days
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
Secondary Outcomes
- Apparent plasma terminal elimination half-life (T1/2)(Up to 21 days)
- Maximum observed plasma concentration (Cmax)(Up to 21 days)
- Time of nadir (Tnadir)(Up to 21 days)
- Area under the effectiveness curve (AUCE)(Up to 21 days)
- The lowest absolute value of lymphocytes at postdose (nadir)(Up to 21 days)
- The lowest percentage of baseline (nadir [%])(Up to 21 days)
- Area under the plasma concentration-time curve (AUC)(Up to 21 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 21 days)