Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: FOY-305

Study type: Interventional

Funder types: Industry

Identifiers

NCT04451083

FOY-305-02

Details and patient eligibility

About

To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Japanese healthy adult male subjects
2. Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas
3. BMI (at the time of screening test): ≥18.5 kg/m2, <25.0 kg/m2

Exclusion criteria

1. Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse
4. Subjects with a history of hypersensitivity caused by ingredients of this drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

FOY-305

Experimental group

Treatment:

Drug: FOY-305