Single Ascending Dose Study of M529101 in Healthy Subjects

Single Ascending Dose Study of M529101 in Healthy male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210455

Enrollment

Registered

2021-11-26

Start date

2021-12-02

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

Oral and Pharyngeal mucositis associated with cancer treatment

Interventions

M529101 or M529101placebo will be swallowed after keeping it in the oral cavity

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety, Pharmacokinetics	—

Secondary

Measure	Time frame
Effects on mouth circumference, oral cavity and pharyngeal functions	—

Contacts

Public ContactClinical Information

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.jp+81-75-325-3279

Outcome results

None listed

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