A single and multiple dose study of M127101 in healthy subjects

JRCT ID: jRCT2071230019

Registered date:07/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nasal polyp accompanies eosinophilic chronic rhinosinusitis
• Date of first enrollment: 26/06/2023
• Target sample size: 16
• Study type: Interventional
• Intervention(s): 2 mL of M127101 or M127101 placebo will be inhaled using a nebulizer once or once a day for 7 days

Outcome(s)

• Primary Outcome: Safety, Tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Male
• Include criteria: Males who are 18 to 44 years of age at the time of informed consent

Exclude criteria

(1)Individuals with a history of respiratory diseases considered inappropriate for participation in the clinical study
(2)Individuals with a history of chronic rhinosinusitis
(3)Individuals who are judged to be unsuitable as subject by the principal (sub) investgator

Related Information

• Primary Sponsor: Tomoyuki Nishiura