Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02488044 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency
A Phase 1 study, sponsored by Aeglea Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02488044 is a Phase 1 study that has completed, run by Aeglea Biotherapeutics. The registered enrollment target is 16 participants.
The verdict
NCT02488044, a Phase 1 study, has completed, sponsored by Aeglea Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued dosing. A data safety monitoring board (DSMB) will provide independent review of study safety data and recommend whether the sponsor should continue the study as planned, modify the study protocol, or discontinue the study.
Interventions
- DRUG AEB1102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02488044
The ClinicalTrials.gov registry entry for NCT02488044 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aeglea Biotherapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AEB1102 is the first listed.
NCT02488044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02488044 about?
NCT02488044 is a clinical study titled "A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency". A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of pediatric and adult patien...
What is the current status of trial NCT02488044?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-06. Estimated completion is 2019-02.
What interventions are being tested in trial NCT02488044?
The interventions under investigation include: AEB1102 (DRUG).
Who is sponsoring clinical trial NCT02488044?
This trial is sponsored by Aeglea Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.