ONO-1110-01:Phase 1 study of the safety, tolerability, pharmacokinetics of ONO-1110 in healthy Japanese adult male subjects

JRCT ID: jRCT2071220100

Registered date:31/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteers(The planned indication has not been determined.)
• Date of first enrollment: 17/02/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

1) Part A:Single dose Part
Subjects receive single oral dose of ONO-1110 or placebo.
2) Part B:Multiple dose Part
Subjects receive multiple oral doses of ONO-1110 or placebo.
3) Part C:Cerebrospinal Fluid Collection Part
Subjects receive single oral dose of ONO-1110.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1) Japanese healthy adult male subjects
2) Age at the time of informed consent: 18 to 45
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: Hirashima Yoshinori