A Phase I study of SCD-044

JRCT ID: jRCT2071240027

Registered date:03/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Psoriasis, Atopic dermatitis
• Date of first enrollment: 16/07/2024
• Target sample size: 36
• Study type: Interventional

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 Outcome: AUC0-inf and Cmax of SCD-044

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both

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

• Primary Sponsor: Toida Tsuneyuki