NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071220100

Registered date:31/01/2023

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHealthy volunteers(The planned indication has not been determined.)
Date of first enrollment17/02/2023
Target sample size100
Countries of recruitment
Study typeInterventional
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 OutcomeSafety (All Part), Pharmacokinetic (All Part), Compound concentration in cerebrospinal fluid (Part C only)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 45age old
GenderMale
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Center Information Medical
Address 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka Osaka Japan 618-8585
Telephone +81-120-626-190
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD
Scientific contact
Name Yoshinori Hirashima
Address 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka Osaka Japan 618-8585
Telephone +81-120-626-190
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD