drugset / Trial / NCT02973802
ATX-GD-59 in Patients With Graves Disease Not Treated With Anti-thyroid Therapy
Phase 1
Completed
12 enrolled
Apitope International NV
European Commission · collabQuintiles, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with Graves Disease not currently treated with anti-thyroid therapy. This will be an open label dose titration involving injections on 10 occasions, each two weeks apart. After dosing is complete there will be a 12 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections. Thyroid function will be measured throughout the trial to monitor Graves disease progression.
Timeline
- Start
- 2016-09
- Primary completion
- 2018-02-14
- Completion
- 2018-02-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ATX-GD-59 | Unknown | 800 ug | Other |