Single Ascending Dose Study of M529101 in Healthy Subjects

JRCT ID: jRCT2031210455

Registered date:26/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Oral and Pharyngeal mucositis associated with cancer treatment
• Date of first enrollment: 02/12/2021
• Target sample size: 32
• Study type: Interventional
• Intervention(s): M529101 or M529101placebo will be swallowed after keeping it in the oral cavity

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics
• Secondary Outcome: Effects on mouth circumference, oral cavity and pharyngeal functions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 35age old
• Gender: Male

Include criteria

(1)Healthy Non-smoking men who are 20 to 34 years of age at the time of informed consent.
(2)BMI of 18.5 to 24.9 kg/m2

Exclude criteria

(1)Individuals with a history of hepatic, renal, cardiac and other cardiovascular, gastrointestinal, hematologic, or other diseases considered inappropriate for paticipation in the clinical study
(2)Individuals with a dental, oral or pharyngeal mucosa disease (including wounds)
(3)Individuals with subjective symptom of dysgeusia

Related Information

• Primary Sponsor: Nishiura Tomoyuki