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NCT02675465 · ClinicalTrials.gov registry record · Phase 1
First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221
A Phase 1 study, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT02675465: Completed Phase 1 study, sponsored by Amicus Therapeutics.
NCT02675465 is a Phase 1 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02675465, a Phase 1 study, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is an international, multi-center, open-label study designed to evaluate if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults with Pompe disease.
Primary Outcome
Number of subjects with TEAE, TESAE, and AE leading to discontinuation during the 2 year treatment period and extension (Stage 3 and 4 combined)
Interventions
- DRUG ATB200
- DRUG AT2221
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-04 |
| Est. Completion | 2024-08-22 |
| Phase | Phase 1 |
What the finished NCT02675465 record still lists
NCT02675465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which ATB200 is the first listed.
NCT02675465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02675465 about?
NCT02675465 is a clinical study titled "First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221". This is an international, multi-center, open-label study designed to evaluate if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults with Pompe disease.
What is the current status of trial NCT02675465?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2016-04. Estimated completion is 2024-08-22.
What interventions are being tested in trial NCT02675465?
The interventions under investigation include: ATB200 (DRUG), AT2221 (DRUG).
Who is sponsoring clinical trial NCT02675465?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02675465's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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