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

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 - A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031175

Enrollment

116

Registered

2018-02-14

Start date

2018-02-05

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

Interventions

CP1050 single oral dose Placebo single oral dose CP1050 oral repeated dose for 21 days Placebo oral repeated dose for 21 days

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary safety endpoints are as follows: - incidence and severity of any drug-related adverse events - vital signs - clinical laboratory evaluations - 12-lead safety ECG - continuous (24-hour) ECG - pulmonary function test - ophthalmological assessments - physical examinations	—

Secondary

Measure	Time frame
The PK endpoints include: - AUClast - AUCinf - Cmax - Tmax - T1/2 The PD endpoints include absolute peripheral lymphocyte count and percentage change of baseline.	—

Countries

Europe

Contacts

Public ContactTadaki Sugawara

Curadim Pharma Co., Ltd. Development Research Division

info@curadim.co.jp81342438654

Outcome results

None listed

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