Pharmacokinetic study of HP-5120

JRCT ID: jRCT2031240331

Registered date:11/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: healthy adult males and females
• Date of first enrollment: 15/10/2024
• Target sample size: 112
• Study type: Interventional

Intervention(s)

[Single ascending dose in healthy adult Japanese males and females]
In Cohort 1, a single dose of HP-5120 Dose 1 or placebo will be administered.
In Cohort 2, a single dose of HP-5120 Dose 2 or placebo will be administered.
In Cohort 3-1, a single dose of HP-5120 Dose 4 or placebo will be administered.
In Cohort 3-2, a single dose of HP-5120 Dose 3 or placebo will be administered.
In Cohort 4, a single dose of HP-5120 Dose 5 or placebo will be administered.

[Single-dose administration by sex in healthy adult Japanese males and females]
In the male group, the maximum tolerated dose of HP-5120 in Dose 1 or 2 will be administered at a single dose.
In the female group, the maximum tolerated dose of HP-5120 in Dose 1 or 2 will be administered at a single dose.

[Multiple doses in healthy Japanese adult males and females]
HP-5120 among Doses 1 to 5 that have been found to be tolerated will be administered for 14 days in repeated dose study.

Outcome(s)

• Primary Outcome: Pharmacokinetics, Safety

Key inclusion & exclusion criteria

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

Include criteria

- Healthy adult Japanese males and females aged 18 or older and younger than 45 years
- Subjects weighing 40 kg or more

Exclude criteria

- Subjects with or with a history of serious cardiovascular, renal, hepatic, gastrointestinal, endocrine, neuropsychiatric, dermatological, metabolic, or immunological disease
- Subjects who received any drug within 1 week prior to administration of the investigational product
- Subjects who took any drug considered to affect drug metabolism within 4 weeks prior to administration of the investigational product

Related Information

• Primary Sponsor: Tanaka Yusuke