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NCT03672604 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects
A Phase 1 study, sponsored by Neuraly.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT03672604: Completed Phase 1 study, sponsored by Neuraly.
NCT03672604 is a Phase 1 study that has completed, run by Neuraly. The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03672604, a Phase 1 study, has completed, sponsored by Neuraly.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study Summary
This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is intended to identify the appropriate dose-range for evaluation in Parkinson's disease patients.
Primary Outcome
Frequency and intensity of treatment-related adverse events as assessed using the CTCAE v4.03 criteria and the DMID Adult Toxicity Table for GI-related events.
Interventions
- DRUG NLY01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2018-09-19 |
| Est. Completion | 2019-07-30 |
| Phase | Phase 1 |
What the finished NCT03672604 record still lists
NCT03672604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 1 intervention - of which NLY01 is the first listed.
NCT03672604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03672604 about?
NCT03672604 is a clinical study titled "A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects". This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is int...
What is the current status of trial NCT03672604?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2018-09-19. Estimated completion is 2019-07-30.
What interventions are being tested in trial NCT03672604?
The interventions under investigation include: NLY01 (DRUG).
Who is sponsoring clinical trial NCT03672604?
This trial is sponsored by Neuraly, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03672604's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 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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