Dose proportional study after single doses intranasal administration of NRL-1 in healthy Japanese subjects

JRCT ID: jRCT2031220272

Registered date:15/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: status epilepticus or seizures that may progress to status epilepticus
• Date of first enrollment: 02/09/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Single intranasal administration of NRL-1 (diazepam, spray)

Outcome(s)

• Primary Outcome: To assess the PK and dose proportionality of NRL-1 after single intranasal administration at 3 doses (5, 10, 20 mg) in healthy Japanese subjects

Key inclusion & exclusion criteria

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

Include criteria

- Japanese males between the ages of 18 and 45 years, inclusive.
- Subjects weigh 51 to 111 kg, inclusive, and have a body mass index (BMI) between 18 and 29 kg/m2, inclusive, at Screening.

• Exclude criteria: A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non-seasonal allergies, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration, or any other condition which, in the opinion of the Investigator or Subinvestigator, may jeopardize the safety of the subject or impact the validity of the study results including chronic rhinitis.

Related Information

• Primary Sponsor: Takazawa Kenji