NCT04151212已完成1 期
A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration
Bio-Thera Solutions1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity(DLT)
研究概览
简要总结
A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 50-80 years old .
- •Signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
- •The study eye must meet all the following inclusion criteria: To be diagnosed as wet age related macular degeneration, and there are still active lesions currently;Total lesion size of ≤30mm2( 12 disc areas);Best corrected visual acuity ≤70 Early Treatment of Diabetic Retinopathy ;Study letters (≤20/40) in the study eye.
- •Best corrected visual acuity ≥34 Early Treatment of Diabetic Retinopathy Study letters (≥20/200) . in the non-study eye.
排除标准
- •There are atrophy of the ground pattern involving the fovea, scar or fibrosis, macular anterior membrane, rigid exudation under dense fovea, RPE tear in the study eye.
- •Retinal hemorrhage ≥4 disc area in the study eye.
- •Dioptric media turbid or the pupil cannot be dilated were significant interference with the detection of vision, the evaluation of the anterior segment and fundus in the study eye.
- •Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g.,Retinal vein occlusion, uveitis, vascular striatum, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease etc).
- •History of vitrectomy surgery\macular transposition\glaucoma filtration in the study eye.
- •Photodynamic therapy(PDT), in macular area laser photocoagulation therapy, transpermary hyperthermia(TTT), and other operations for AMD within 3 months prior to screening visit in the study eye.
- •History of extraocula surgeryr within 1 months or cataract surgery within 3 months prior to screening visit in the study eye.
- •Aphakia(exclusive of intraocular lens) or rupture of posterior capsule( within1 months prior to the YAG laser retrovesiculotomy (after the artificial crystal), was excluded) in the study eye.
- •APD in the study eye or pseudocyst stripping syndrome in either eye.
- •Intravitrea or Systemicl anti-VEGF injection (ranibizumab, aflibercept, bevacizumab or Conbercept etc) in either eye within 3 months prior to screening visit.
- •Under the conjunctiva,intravitreal or periocular corticosteroid, within 3 months prior to screening visit in either eye.
- •vitreous hemorrhage within 3 months prior to screening Visit in either eye.
- •Ocular or periocular infection in either eye.
- •History of glaucoma in either eye.
- •Visudyne (verteporfin) photodynamic therapy within 1 months prior to screening Visit in non-study eye.
- •Currently in use or may be required to use systemic drugs that cause crystal toxicity or retinal toxicity, such as Deferoxamine, chloroquine/ hydroxychloroquine, phenothiazine and ethambutol or tamoxifen etc.
- •Have an allergic reaction or history of allergic reactions to fluorescein sodium and indocyanine green, an allergic history to therapeutic or diagnostic protein products, an allergic reaction to more than two drugs or non-drug factors, or allergic reactions to any monoclonal antibody.
- •Patients with diabetic retinopathy or the diabetic patient who have glycosylated? hemoglobin>10%.
- •Patients who have undergone any surgical operation within 1 month prior screening; or/and there are unhealed wounds, ulcers, fractures etc.
- •Systemic infectious diseases with clinical significance requiring oral, intramuscular or Patients withintravenous administration.
- •Myocardial infarction, cerebral infarction and angina pectoris within 6 months prior to screening visit.
- •Patients with active disseminated intravascular coagulation and obvious bleeding tendency were screened within 3 months before the screening, or they were treated with anticoagulant and antiplatelet therapy other than aspirin/NSAIDs within 14 days before the screening.
- •Patients with Systemic immune disease ,including but not limited to:
- •hyperthyroidism, hypothyroidism,vitiligo, dry-syndrome, ankylosing spondylitis, systemic nephritis, human immunodeficiency virus (HIV).
- •Blood pressure control is not ideal or pre-hypertension.
- •Any uncontrollable clinical problems (Serious mental, nervous, cardiovascular and respiratory diseases and malignant tumors).
- •Abnormal liver and kidney function.
- •Blood coagulation is abnormal.
- •Patients with AIDS, syphilis or active hepatitis.
- •Women are not using effective contraception or in pregnancy,lactation.
- •Clinical trials of any trial medication or any other experimental or experimental therapy may be performed within 3 months prior to screening.
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
研究组 & 干预措施
BAT5906 injection
Experimental
Single dose escalation starting from 0.3mg. Route of administration: intravitreal injection.
干预措施: BAT5906 injection (Drug)
结局指标
主要结局
Dose-limiting toxicity(DLT)
时间窗: 2 weeks
Safety and tolerability endpoint
Maximum tolerated dosed(MTD)
时间窗: 0-70days
Safety and tolerability endpoint
Half-life period(t1/2)
时间窗: 0-70days
Pharmacokinetic endpoint
Area under the curve(AUC0-t, AUC0-inf)
时间窗: 0-70days
Pharmacokinetic endpoint Pharmacokinetic endpoint
Plasma clearance(CL)
时间窗: 0-70days
Pharmacokinetic endpoint
Maximum serum drug concentration(Cmax)
时间窗: 0-70days
Pharmacokinetic endpoint Pharmacokinetic endpoint
Maximum serum drug time(Tmax)
时间窗: 0-70days
Pharmacokinetic endpoint
次要结局
- Central Retinal thickness(CRT)(0-70days)
- Anti-drug antibodies(ADA)(0-70days)
- VEGF concentration(0-70days)
- Best correct vision(BCVA)(0-70days)
研究者
研究点 (1)
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