臨床研究等提出・公開システム

A Phase 1, randomized, placebo-controlled, double-blind, single and multiple dose study of M127101 in healthy subjects

A single and multiple dose study of M127101 in healthy subjects

16

Single-dose phase: (1) 0.0003% M127101 group(M127101 group) Age (mean): 22.8 years Sex: 6 male participants Race: 100% Asian (2) M127101 vehicle group(vehicle group) Age (mean): 23.5 years Sex: 2 male participants Race: 100% Asian Repeated-dose phase: (1) M127101 group Age (mean): 22.7 years Sex: 6 male participants Race: 100% Asian (2) Vehicle group Age (mean): 23.0 years Sex: 2 male participants Race: 100% Asian

Single-dose phase: (1) M127101 group Study Drug Administered: 6 participants Completed: 5 participants Discontinued: 1 participant (2) Vehicle group Study Drug Administered: 2 participants Completed: 2 participants Discontinued: 0 participants Repeated-dose phase: (1) M127101 group Study Drug Administered: 6 participants Completed: 6 participants Discontinued: 0 participants (2) Vehicle group Study Drug Administered: 2 participants Completed: 1 participant Discontinued: 1 participant

The safety analysis was performed on the safety analysis population, which included 8 participants each in the single-dose and repeated-dose studies (6 in the M127101 group, 2 in the vehicle group). One participant in the repeated-dose phase experienced adverse events of alanine aminotransferase increased and gamma-glutamyltransferase increased, both of which were not related to the study drug, non-serious, mild in severity, and resolved without treatment. Furthermore, respiratory function-related events, coagulation/fibrinolysis-related events, or symptoms suggestive of allergic reactions, which were adverse events of special interest, did not occur. No clinically significant changes were detected in clinical laboratory values, vital signs, electrocardiograms, chest X-rays, and respiratory function tests.

Not applicable since only safety evaluations were performed in this study.

When 0.0003% M127101 was administered to healthy adult men as a single dose or as a once-daily intranasal administration for 7 days, M127101 was well tolerated with no safety concerns identified.

Feb. 10, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071230019

Tomoyuki Nishiura

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

- Clinical Trials Information

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

June. 07, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Males who are 18 to 44 years of age at the time of informed consent

(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

Male

Nasal polyp accompanies eosinophilic chronic rhinosinusitis

2 mL of M127101 or M127101 placebo will be inhaled using a nebulizer once or once a day for 7 days

Safety, Tolerability

+81-92-283-7701

June. 22, 2023

none