A Multicenter, Non-Randomized, Open-Label, Multiple-Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Visara, Inc.
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 2. Incidence of non-ocular AEs
研究概览
简要总结
This multicenter, non-randomized, open-label, multiple-dose-escalation and dose-expansion study will investigate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 following intravitreal administration in patients with diabetic macular edema (DME).
详细描述
Part 1 of this study is a multicenter, open-label, sequentially, multiple-dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Patients will be sequentially enrolled into four different dose-level cohorts following accelerated titration combined with the traditional "3+3" design.
Part 2 of this study was planned to be a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Part 2 was not initiated due to a strategic decision by the sponsor not related to safety or efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- •Hemoglobin A1c of less than or equal to 12%
- •For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment
- •Ability and willingness to undertake all scheduled visits and assessments
- •Macular thickening secondary to DME involving the center of the fovea
- •Decreased visual acuity attributable primarily to DME
排除标准
- •History of allergy or current allergic response to ASKG712 or fluorescein
- •Diseases that affect intravenous injection and venous blood sampling
- •Uncontrolled blood pressure
- •Systemic autoimmune diseases
- •Previous anti-VEGF drug treatment
- •Currently pregnant or breastfeeding, or intend to become pregnant during the study
- •Any uncontrolled clinical disorders
- •Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- •History of intraocular or periocular corticosteroid treatment in the study eye
- •Uncontrolled previous or current glaucoma in the study eye
- •Previous intraocular operations in the study eye
- •Active intraocular or periocular infection or active intraocular inflammation in the study eye
- •History of uveitis in either eye
- •Other protocol-specified inclusion/exclusion criteria may apply
研究组 & 干预措施
ASKG712
Multiple doses of ASKG712 by intravitreal injection
干预措施: ASKG712 (Biological)
结局指标
主要结局
2. Incidence of non-ocular AEs
时间窗: 24 weeks
Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
1. Incidence of ocular adverse events (AEs) of the study eyes
时间窗: 24 weeks
Any relevant ocular observations derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography
次要结局
- 4. Change From Baseline in BCVA in the Study Eye Over Time(24 weeks)
- 1. Area under the concentration time curve (AUC)(24 weeks)
- 3. Incidence of Anti-Drug Antibody (ADA)(24 weeks)
- 2. Maximum plasma concentration (Cmax)(24 weeks)