NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071240027

Registered date:03/07/2024

A Phase I study of SCD-044

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPsoriasis, Atopic dermatitis
Date of first enrollment16/07/2024
Target sample size36
Countries of recruitment
Study typeInterventional
Intervention(s)For cohort-1, male and female Caucasian subjects will receive single oral dose administration of SCD-044 at a dose of 2 mg under fasting conditions. Cohort-2 consist of three periods. Male Japanase subjects will receive single oral dose administration of SCD-044 at a dose of 1mg in Period1, 2 mg in Period 2, 4mg in Period 3 or placebo under fasting conditions. Female Japanese subjects will receive 2mg or placeob in Period 2 under fasting conditions.

Outcome(s)

Primary OutcomeAUC0-inf and Cmax of SCD-044
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 50age old
GenderBoth
Include criteria- Adult males aged between18 and 50 years with body mass index (BMI) between 18 and 28 kg/m2. - Adult females (non-pregnant, non-lactating) aged between 18 and 50 years with BMI between 18 and 28 kg/m2. - (only for cohort 1) Subjects of Caucasian descent as defined by 1) having 2 parents and 4 grandparents of Caucasian including White and Hispanic ethnicities, and 2) maintaining a Western lifestyle. - (only for cohort 2) Subjects of native Japanese descent as defined by 1) having 2 parents and 4 grandparents of Japanese descent, 2) not residing outside of Japan for >=10 years, and 3) maintaining a Japanese lifestyle.
Exclude criteria- History or presence of clinically relevant, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other systemic disease or history of any major surgical conditions within 4 weeks prior to the screening condition consider to that may affect compromise subject safety or interfere with the evaluation of the safety based on the judgment of the investigator. No Surgery is to be planned during the length of the study. - At screening the subject has any conditions or treatments that may affect cardiovascular function. - History of macular edema or diagnosed before administration of study drug will be excluded. - History or presence of uveitis or are currently complicated. - Any subjects the investigator considers ineligible.

Related Information

Contact

Public contact
Name Tomoe Yamanaka
Address KDX Hamamatsucho Place 1-7-6 Shibakoen, Minato-ku, Tokyo Tokyo Japan 105-0011
Telephone +81-3-6432-0201
E-mail JPS.clinicaltrial@sunpharma.com
Affiliation Sun Pharma Japan Limited
Scientific contact
Name Tsuneyuki Toida
Address KDX Hamamatsucho Place 1-7-6 Shibakoen, Minato-ku, Tokyo Tokyo Japan 105-0011
Telephone +81-3-6432-0201
E-mail JPS.clinicaltrial@sunpharma.com
Affiliation Sun Pharma Japan Limited