NCT05639530进行中（未招募）1 期
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety and tolerance indicators
研究概览
简要总结
This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- •Male or female patients ≥ 50 yrs. of age.
- •Active CNV lesions secondary to neovascular AMD.
- •BCVA score of 19-78 letters using ETDRS charts in the study eye.
- •Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.
排除标准
- •Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- •Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
- •Active ocular or periocular inflammation/infection in either eye;
- •Prior any treatment of following in the study eye:
- •Anti-VEGF therapy within 90 days prior to screening;
- •Intraocular glucocorticoid injection within 180 days prior to screening;
- •Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
- •Intraocular surgery within 90 days prior to screening;
- •Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
- •Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;
- •Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
- •Systemic administration of steroids within 30 days prior to screening;
- •Systemic administration of anti-VEGF drugs within 90 days prior to screening;
- •History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- •Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study;
- •Other conditions unsuitable for enrollment judged by investigators.
结局指标
主要结局
Safety and tolerance indicators
时间窗: Through study completion, a maximum of 24 weeks
1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;
次要结局
- Maximum concentration (Cmax) of the drug after the administration.(Through study completion, a maximum of 24 weeks)
- Time at which maximum concentration (Tmax) occurs for the drug after the administration.(Through study completion, a maximum of 24 weeks)
- Number of participants with anti-drug antibodies or neutralizing antibodies .(Through study completion, a maximum of 24 weeks)
- Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.(Through study completion, a maximum of 24 weeks)
- The area under the curve (AUC) of serum concentration of the drug after the administration.(Through study completion, a maximum of 24 weeks)
- The half-life (t1/2) of drug after the administration .(Through study completion, a maximum of 24 weeks)
- Changes of BCVA measured by ETDRS chart from baseline.(Through study completion, a maximum of 24 weeks)
- Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.(Through study completion, a maximum of 24 weeks)
- Change of height of pigment epithelial detachment from baseline on SD-OCT.(Through study completion, a maximum of 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular EdemaDiabetic Macular EdemaNCT05489718Innovent Biologics (Suzhou) Co. Ltd.24
已完成
1 期
Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD PatientsNeovascular Age-related Macular DegenerationNCT04370379Innovent Biologics (Suzhou) Co. Ltd.18
已完成
1 期
A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular DegenerationNeovascular Age-related Macular DegenerationNCT03814291Innovent Biologics (Suzhou) Co. Ltd.31
招募中
1 期
A Study of ASKG315 in Patients With Advanced Solid Tumors.Advanced Solid TumorsNCT05554666AskGene Pharma, Inc.56
尚未招募
1 期
A Phase 1 Study of ASKG315 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05509985AskGene Pharma, Inc.100