A two-part, open-label study to assess the pharmacokinetics, pharmacodynamics and safety of single doses of inhaled and intravenously administered D,L lysine acetylsalicylate • glycine (LASAG) in healthy adult subjects: Study Part A follows a randomized, cross-over design to compare three dose levels of inhaled LASAG to one dose level of intravenously administered LASAG and Study Part B follows a single group design to investigate a XXXXX LASAG inhalation solution.
Phase 1
- Conditions
- Phase I, Clinical trial in healthy males and femalesintended indication: migraineMedDRA version: 21.1Level: LLTClassification code: 10010108Term: Common migraine Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Registration Number
- CTIS2022-503037-63-00
- Lead Sponsor
- Aspiair GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method