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NCT04969497 · ClinicalTrials.gov registry record · Phase 1
Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers
A Phase 1 study, sponsored by Zosano Pharma Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04969497: Completed Phase 1 study, sponsored by Zosano Pharma Corporation.
NCT04969497 is a Phase 1 study that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04969497, a Phase 1 study, has completed, sponsored by Zosano Pharma Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence and type of adverse events reported and observed
Interventions
- DRUG Treatment A: M207 3.8 mg "MiniMac"
- DRUG Treatment B: M207 3.8 mg "MACAP"
- DRUG Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 1 |
What the finished NCT04969497 record still lists
NCT04969497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Treatment A: M207 3.8 mg "MiniMac" is the first listed.
NCT04969497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04969497 about?
NCT04969497 is a clinical study titled "Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers". 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 ...
What is the current status of trial NCT04969497?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2021-06-24. Estimated completion is 2021-09-02.
What interventions are being tested in trial NCT04969497?
The interventions under investigation include: Treatment A: M207 3.8 mg "MiniMac" (DRUG), Treatment B: M207 3.8 mg "MACAP" (DRUG), Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 (DRUG).
Who is sponsoring clinical trial NCT04969497?
This trial is sponsored by Zosano Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04969497's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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