drugset / Trial / NCT02613559
Evaluation the Pharmacokinetics, Safety, Tolerability of TK001 in Patients With Neovascular Age-related Macular Degeneration
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and tolerability of single ascending doses of TK001(Recombinant humanized anti-VEGF monoclonal antibody) to determine the maximum tolerated dose (MTD) in neovascular wet age-related macular degeneration (wAMD) subjects.
Timeline
- Start
- 2015-11
- Primary completion
- 2018-06
- Completion
- 2018-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TK001 | Monoclonal antibody | 0.1 mg | Intravitreal |
| Subject | TK001 | Monoclonal antibody | 0.5 mg | Intravitreal |
| Subject | TK001 | Monoclonal antibody | 1 mg | Intravitreal |
| Subject | TK001 | Monoclonal antibody | 2 mg | Intravitreal |
| Subject | TK001 | Monoclonal antibody | 2.5 mg | Intravitreal |
| Subject | TK001 | Monoclonal antibody | 3 mg | Intravitreal |