Trials / Unknown
UnknownNCT03021785
A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration
A Multi-center, Open-label Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-Related Macular Degeneration
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd · Industry
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks).
Detailed description
This is a multicenter, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks). In the core study, patients will receive their assigned dose in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose. The safety, pharmacokinetics, immunogenicity, and preliminary efficacy of TK001 will be evaluated in the core study, and will also be assessed in the extension study except pharmacokinetics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TK001 | TK001 will be administered intravitreal injection. |
Timeline
- Start date
- 2017-10-18
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2017-01-16
- Last updated
- 2018-03-01
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03021785. Inclusion in this directory is not an endorsement.