A First-in-human Phase 1 Study of CP1050

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03468413
• Other study ID #: CP1050-E101
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: February 22, 2018
• Last updated: March 11, 2018
• Start date: February 5, 2018
• Est. completion date: February 2019

Study information

• Verified date: March 2018
• Source: Curadim Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 116
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• CP1050 or Placebo
Randomised, double-blinded, placebo-controlled

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (CRU) Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Curadim Pharma Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Maximum observed plasma concentration (Cmax)		Up to 21 days
Secondary	Area under the plasma concentration-time curve (AUC)		Up to 21 days
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 21 days
Secondary	Apparent plasma terminal elimination half-life (T1/2)		Up to 21 days
Secondary	The lowest absolute value of lymphocytes at postdose (nadir)		Up to 21 days
Secondary	The lowest percentage of baseline (nadir [%])		Up to 21 days
Secondary	Time of nadir (Tnadir)		Up to 21 days
Secondary	Area under the effectiveness curve (AUCE)		Up to 21 days