A phase I clinical study of KSP-0243

JRCT ID: jRCT2071200087

Registered date:20/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Condition
• Date of first enrollment: 18/01/2021
• Target sample size: 144
• Study type: Interventional
• Intervention(s): KSP-0243 single or multiple oral dose

Outcome(s)

• Primary Outcome: Adverse event

Secondary Outcome

Adverse drug reaction
Vital sign
12-lead ECG
Laboratory test
Plasma pharmacokinetics profile
Urine excretion profile

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male
• Include criteria: BMI: Between 18.5 kg/m^2 or greater and less than 25 kg/m^2 in Japanese, between 18.5 kg/m^2 or greater and less than 30 kg/m^2 in Caucasian.
• Exclude criteria: Participants with any abnormal findings (e.g. clinical laboratory test values outside the reference range) during the physical examination and other tests (vital signs, 12-lead ECG and clinical laboratory tests) that are judged by investigators to be clinically significant

Related Information

• Primary Sponsor: Shimizu Yoshitaka