Status:
UNKNOWN
A First-in-human Phase 1 Study of CP1050
Lead Sponsor:
Curadim Pharma Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03468413
Start Date
February 5 2018
End Date
February 1 2019
Last Update
March 16 2018
Active Locations (1)
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1
Covance Clinical Research Unit (CRU) Ltd.
Leeds, United Kingdom, LS2 9LH