A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults

A Phase-1, Open-label Randomized, 4-treatment, 4-period Crossover Study to Evaluate the Pharmacokinetics, Relative Bioavailability, Safety and Tolerability of Single Doses of Dihydroergotamine Mesylate (DHE) Inhalation Powder, DHE Intravenous (IV), and DHE Nasal Spray in Healthy Adult Subjects.

A Phase 1 clinical trial to evaluate the pharmacokinetics, relative bioavailability, safety and tolerability of DHE inhalation powder delivered by dry powder inhaler, DHE IV, and DHE nasal spray.

This is an open-label, randomized, 4-treatment, 4-period crossover study to evaluate the PK, relative BA, safety, and tolerability of single doses of study medication in healthy adult subjects.

Following screening, eligible subjects will be enrolled and randomized to one of the 4 treatment sequences. Subjects will receive single doses of DHE inhalation powder (low dose and high dose), DHE IV (1 mg) and DHE nasal spray (2 mg).

Subjects will be administered one treatment in each period according to their assigned sequence. Each subject will receive all 4 treatments in the study.

During each treatment period subjects will remain in the clinical research unit for 3 days, until completion of the 48-hour post-dose assessments.

Subjects will return for their next treatment period after at least 7 days washout after the administration of their previous treatment until all periods have been completed in their sequence.

A follow-up will be conducted on Day 7 after the last dose in the study to assess safety.

Inclusion Criteria:

• Subjects must meet all the following criteria to be included in the study:

  1. Male or female, ≥ 18 and ≤ 55 years of age, with body mass index (BMI) >18.5 and < 32.0 kg/m2
  2. Healthy subjects
  3. Female subjects of non-childbearing potential or childbearing potential willing to use protocol required methods of contraception
  4. Current non-smoker
  5. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria:

• Subjects to whom any of the following applies will be excluded from the study:

  1. Positive pregnancy test or lactating female subjects at screening or on Day 1 of each treatment period
  2. Clinically significant abnormal laboratory or serology test results
  3. History or current diagnosis of uncontrolled or significant cardiac disease
  4. Significant risk factors for cardiovascular disease
  5. Subject with abnormal lung function at screening
  6. History or current diagnosis of lung disease e.g. asthma, COPD
  7. Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
  8. History of drug or alcohol abuse