drugset / Trial / NCT04969497

Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers

NCT04969497

Phase 1 Completed 48 enrolled Zosano Pharma Corporation
RandomizedCrossoverOpen-labelTreatment

Summary

This is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis. Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.

Timeline

Start
2021-06-24
Primary completion
2021-09-02
Completion
2021-09-02

Drugs

EvaluationDrugModalityDoseRoute
Subject M207 Unknown 3.8 mg Other
Subject Zolmitriptan Small molecule 5 mg Intranasal

Indications