A Phase I, Single-dose Study with SB206 in Healthy Japanese Adults

JRCT ID: jRCT2031220073

Registered date:19/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Molluscum contagiosum
• Date of first enrollment: 23/06/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): SB206 and vehicle are applied.

Outcome(s)

• Primary Outcome: Skin irritation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

1. Healthy Japanese adult males aged 20 to 40 years at the time of obtaining written informed consent
2. Subjects with a body mass index (BMI) of 18.5 to 25.0 at screening
3. Subjects who are considered by the investigator or subinvestigator as acceptable for inclusion in the study as judged from the results of observation and examination upon screening and hospitalization
4. Subjects who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent

Exclude criteria

1. Subjects with a history of drug allergy
2. Subjects with a history of food allergy
3. Subjects with a history of contact dermatitis, such as adhesive tape dermatitis, or mechanical urticaria
4. Subjects considered ineligible for the study by the investigator or subinvestigator

Related Information

• Primary Sponsor: Tsubouchi Ichiro