ONO-2808-02:ONO-2808 Phase 1 study

JRCT ID: jRCT2071200099

Registered date:15/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neurodegenerative disorder
• Date of first enrollment: 01/03/2021
• Target sample size: 62
• Study type: Interventional

Intervention(s)

1) Part A: Single Japanese Part
A single-dose, dose-escalation, placebo-controlled, double-blind, randomized, parallel-group study in healthy Japanese adult male subjects.
2) Part B (Japanese elderly single dose part)
A single-dose, uncontrolled, open-label study in elderly Japanese men and women.
3) Part C (Japanese Multiple dose part)
A multiple-dose, placebo-controlled, double-blind, randomized, parallel-group study in healthy Japanese adult male subjects.

Outcome(s)

• Primary Outcome: Safety (All Part), Pharmacokinetic (All Part), Compound concentration in cerebrospinal fluid (Part C only)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

<Japanese healthy adult males and elderly males/females>
1) Japanese healthy adult male subjects, Japanese elderly male or female subjects
2) Age at the time of informed consent: 20 to 45 (Healthy adults), 65 to 74 (Elderly males/Elderly females)
3) BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2

Exclude 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

Related Information

• Primary Sponsor: Osawa Masahiro