Trials / Completed
CompletedNCT04151212
A Phase I Clinical Trial of BAT5906 Injection in Patients With Wet Age-related Macular Degeneration
A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Bio-Thera Solutions · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.
Detailed description
The primary objective: To evaluate the safety and Pharmacokinetics of BAT5906 (single-dose Ophthalmic Intracireal Iinjection) in patients wAMD , when the injection dosage escalates. The Secondary objective: To evaluate the immunogenicity profile of BAT5906; To evaluate the pharmacodynamics and therapeutic efficacy profile of BAT5906.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAT5906 injection | Signal dose escalation starting from 0.3mg. Route of administration: intravitreal injection |
Timeline
- Start date
- 2018-10-30
- Primary completion
- 2021-02-28
- Completion
- 2021-04-30
- First posted
- 2019-11-05
- Last updated
- 2021-09-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04151212. Inclusion in this directory is not an endorsement.