A First-in-human Phase 1 Study of CP1050
- Conditions
- Healthy Subjects
- Interventions
- Drug: CP1050 or Placebo
- Registration Number
- NCT03468413
- Lead Sponsor
- Curadim Pharma Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple ascending dose, CP1050 or Placebo CP1050 or Placebo - Single ascending dose, CP1050 or Placebo CP1050 or Placebo -
- Primary Outcome Measures
Name Time Method 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]) 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) 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) 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 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]) 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 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 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) 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit (CRU) Ltd.
🇬🇧Leeds, United Kingdom