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NCT07635095 · ClinicalTrials.gov registry record · Phase 1
A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants
A Phase 1 study, sponsored by Astria Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT07635095: Recruiting Phase 1 study, sponsored by Astria Therapeutics.
NCT07635095 is a Phase 1 study that is actively recruiting participants, run by Astria Therapeutics. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07635095, a Phase 1 study, is actively recruiting participants, sponsored by Astria Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are: * Do these presentations lead to similar drug concentrations in the blood? * Do these presentations lead to similar safety and tolerability? Researchers will compare the drug concentrations and safety profile of each group to determine if they are similar. Participants will: * Receive one dose of navenibart with either the vial and syringe or the autoinjector. * Stay in the clinic beginning one day prior to dosing through 2 days after dosing. * Return to the clinic for approximately 9 additional non-residential visits. * Complete medical and other testing, including blood draws.
Primary Outcome
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Interventions
- COMBINATION_PRODUCT Autoinjector
- DRUG Vial and syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-04-21 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT07635095 shows while recruiting
NCT07635095 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher).
The record links to 0 conditions, and to 2 interventions - of which Autoinjector is the first listed.
NCT07635095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07635095 about?
NCT07635095 is a clinical study titled "A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants". The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are: * Do these presentations lead to similar drug concentrations in the blood? * Do these presentations l...
What is the current status of trial NCT07635095?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2026-04-21. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07635095?
The interventions under investigation include: Autoinjector (COMBINATION_PRODUCT), Vial and syringe (DRUG).
Who is sponsoring clinical trial NCT07635095?
This trial is sponsored by Astria Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07635095's enrollment target sits among peer trials
180 299th of 2000 higher than 1,690 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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