A First-in-human Phase 1 Study of CP1050

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: CP1050 or Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending dose, CP1050 or Placebo<br> | Drug: CP1050 or Placebo<br>* Randomised, double-blinded, placebo-controlled<br>|
| Experimental: Multiple ascending dose, CP1050 or Placebo<br> | Drug: CP1050 or Placebo<br>* Randomised, double-blinded, placebo-controlled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Up to 21 days | 
| Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only]) | 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 | 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 | 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 | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | 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 | 
| Apparent plasma terminal elimination half-life (T1/2) |  | 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 | 
| Time of nadir (Tnadir) |  | Up to 21 days | 
| Area under the effectiveness curve (AUCE) |  | Up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CP1050, Phase 1, Healthy subjects