Clinical trial NCT03468413: A First-in-human Phase 1 Study of CP1050
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: CP1050
Phase 1
Healthy subjects
Lead sponsor: Curadim Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Incidence and severity of any drug-related adverse events
timeFrame: Up to 21 days
measure: Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)
timeFrame: Up to 21 days
measure: Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)
timeFrame: Up to 21 days
measure: 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])
timeFrame: Up to 21 days
measure: 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)
timeFrame: Up to 21 days
measure: Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])
timeFrame: Up to 21 days
measure: Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT
timeFrame: Up to 21 days
measure: Number of subjects with abnormal physical examinations
timeFrame: Up to 21 days
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 21 days
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 21 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 21 days
measure: Apparent plasma terminal elimination half-life (T1/2)
timeFrame: Up to 21 days
measure: The lowest absolute value of lymphocytes at postdose (nadir)
timeFrame: Up to 21 days
measure: The lowest percentage of baseline (nadir [%])
timeFrame: Up to 21 days
measure: Time of nadir (Tnadir)
timeFrame: Up to 21 days
measure: Area under the effectiveness curve (AUCE)
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd.
Study officials:
References: