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

Phase 1

• Conditions: status epilepticus or seizures that may progress to status epilepticus

• Registration Number: JPRN-jRCT2031220272
• Lead Sponsor: Takazawa Kenji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified