The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)
NCT04151407 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-11-05
Summary
Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME.
Conditions
Interventions
- DRUG
-
Drug 601
Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
Sponsors & Collaborators
-
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-08
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- China
Study Locations
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