ONO-1110-02:A PET Study to Evaluate Target Molecule Occupancy in the Brain of ONO-1110 in Healthy Japanese Adult Males

JRCT ID: jRCT2071230063

Registered date:14/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers(The planned indication has not been determined.)
• Date of first enrollment: 30/09/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

1) Part A:Subjects receive single intravenous administration of ONO-SE-853(18F).
2) Part B:In the period1, subjects receive single intravenous administration of ONO-SE-853(18F). In the period2, subjects receive single oral dose of ONO-1110 and single intravenous administration of ONO-SE-853(18F).

Outcome(s)

• Primary Outcome: Target Molecule Occupancy in the Brain of ONO-1110 after single oral dose of ONO-1110 in Healthy Adult Males.

Secondary Outcome

1)Safety, biodistribution and dosimetry of ONO-SE-853(18F)
2)Evaluation of Brain-targeting potential of ONO-SE-853(18F)
3)Evaluation of the relationship between plasma ONO-1110 concentration or ONO-1110 dose and target molecule occupancy of ONO-1110 in the brain
4)Safety of ONO-1110
5)Plasma ONO-1110 Concentrations

Key inclusion & exclusion criteria

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

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 30.0 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