First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221
Public ClinicalTrials.gov record NCT02675465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Fixed-Sequence, Ascending-Dose, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous Infusions of ATB200 Co-Administered With Oral AT2221 in Adult Subjects With Pompe Disease
Study identification
- NCT ID
- NCT02675465
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Amicus Therapeutics
- Industry
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Interventions
- AT2221 Drug
- ATB200 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2016
- Primary completion
- Aug 21, 2024
- Completion
- Aug 21, 2024
- Last update posted
- Oct 22, 2025
2016 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuromuscular Research Centre | Phoenix | Arizona | 85028 | — |
| University of California Irvine | Orange | California | 92868 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Emory University Division of Medical Genetics | Decatur | Georgia | 30033 | — |
| Infusion Associates | Grand Rapids | Michigan | 49525 | — |
| Great Falls Clinic, LLP | Great Falls | Montana | 59405 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 08103 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Abramson Cancer Center Chester County Hospital | West Chester | Pennsylvania | 19380 | — |
| Lysosomal & Rare Disorders Research & Treatment Center (LDRTC) | Fairfax | Virginia | 22030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02675465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2025 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02675465 live on ClinicalTrials.gov.