A First-in-human Phase 1 Study of CP1050

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

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).

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.