A phase I clinical study of KSP-0243

A phase I clinical study of KSP-0243 in Japanese and Caucasian healthy adult males

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200087

Enrollment

144

Registered

2021-01-20

Start date

2021-01-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Condition

Interventions

KSP-0243 single or multiple oral dose

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Adverse event	—

Secondary

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

Contacts

Public ContactYoshitaka Shimizu

Kissei Pharmaceutical Co., Ltd.

rinsyousiken@pharm.kissei.co.jp+81-120-007-622

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026