A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in
healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration
in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover
manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE
mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover
manner.

Inclusion Criteria:

- 18 to 50 years of age at the time of enrollment.

- Signed the informed consent document.

- Subject judged to be healthy by a qualified physician

Exclusion Criteria:

- Abnormal physical findings of clinical significance at the screening examination

- Significant abnormal laboratory values at the Screening Visit.

- Clinically significant symptoms or conditions that may have placed the subject at an
unacceptable risk as a participant in the trial, or that may have interfered with the
absorption, distribution, metabolism or excretion of the IMP.