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A Phase I study of SCD-044

A Phase I study to evaluate the pharmacokinetics, safety, and tolerability of SCD-044 in healthy adult subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071240027
Enrollment
36
Registered
2024-07-03
Start date
2024-07-16
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

Psoriasis, Atopic dermatitis

Interventions

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 su

Sponsors

Toida Tsuneyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
AUC0-inf and Cmax of SCD-044

Contacts

Public ContactTomoe Yamanaka

Sun Pharma Japan Limited

JPS.clinicaltrial@sunpharma.com+81-3-6432-0201

Outcome results

None listed

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