Safety, tolerability, and pharmacokinetics of intravenous Investigational product in Japanese healthy adults

JRCT ID: jRCT2071240007

Registered date:19/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy participants
• Date of first enrollment: 22/04/2024
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Each cohort 1-3 (n=12 in each cohort) was devided into Subcohort A(n=4) and Subcohort B (n=8).
- Subcohort A (1-A,2-A,3-A) :
- Single dose of Investigational product (n=3 in each cohort))
- Single dose of placebo (n=1 in each cohort))
- Subcohort B (1-B,2-B,3-B) :
- Single dose of Investigational product (n=6 in each cohort))
- Single dose of placebo (n=2 in each cohort))

Outcome(s)

• Primary Outcome: Treatment emergent adverse events, vital signs, ECG data, laboratory assessments,Columbia Suicide Severity Rating Scale (C-SSRS), Profile of Mood States (POMS), and local tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old

Include criteria

- Written informed consent must be obtained before any assessment is performed.
- Healthy Japanese males and females of non-child bearing potential aged 18 to 55 years of age, inclusive, and in good health as determined by past medical history and screening and baseline assessments.
- Participants must weigh at least 40.0 kg and at maximum 100.0 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2, inclusive.

Exclude criteria

- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities:
- PR > 200 msec
- QRS complex > 120 msec
- QTcF > 450 msec (males)
- QTcF > 460 msec (females)
- History of neurological disorders
- Use of any prescription drugs, herbal supplements, within 4 weeks or 5-half-lives whichever is longer prior to initial dosing, and over-the-counter (OTC) medication, dietary supplements (vitamins included) within two weeks or 5-half-lives whichever is longer prior to initial dosing.
- Donation or loss of 400 mL or more of blood within 16 weeks prior to first dosing
- Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in case of participation in the study.
- Participants with spinal deformities, in the opinion of the investigator, that would preclude the subject participation for CSF collection during the study

Related Information

• Primary Sponsor: Sinmyo Satoru
• Secondary ID(s): Nil known