status epilepticus or seizures that may progress to status epilepticus
Conditions
Interventions
Single intranasal administration of NRL-1 (diazepam, spray)
Sponsors
Takazawa Kenji
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactJunichi Onuma
Aculys Pharma, Inc.
Outcome results
None listed