NCT04594681终止1 期
A Phase I Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability after administration of KHK4951 in healthy volunteers and patients with wet age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Voluntary written informed consent to participate in the study
- •Japanese or white men 20 to < 50 years at the time of informed consent
- •BMI 18.5 to < 30.0 at screening
- •Intraocular pressure (study eye) 10.0 mm Hg to 21.0 mm Hg
- •Monocular or binocular visual acuity (corrected visual acuity if correction is required) ≥ 1.0 at screening
- •Inclusion Criteria: Patients
- •Voluntary written informed consent to participate in the study
- •Age ≥ 50 years at the time of informed consent
- •AMD-associated by active subfoveal CNV lesions in the study eye or juxtafoveal CNV lesions with CNV-associated findings in the fovea in the study eye
- •CST ≥ 300 μm in the study eye at screening, as measured by OCT
- •BCVA score ≥ 23 letters in the study eye at screening and enrollment, as measured by the ETDRS visual acuity chart
- •BCVA score ≥ 58 letters in the non-study eye at screening, as measured by the ETDRS visual acuity chart
- •In subjects with prior treatment of the study eye with anti-vascular endothelial growth factor (anti-VEGF) drugs such as Beovu, Eylea, Lucentis, Avastin, or Macugen, presence of response to the anti-VEGF drug(s) as judged by the investigator or subinvestigator based OCT, FA, visual acuity, or other assessment results
排除标准
- •Healthy Volunteers
- •Current illness requiring treatment
- •History of ophthalmologic laser surgery, ophthalmologic surgery, nasolacrimal duct surgery, orany eyelid surgery affecting flow in the nasolacrimal duct
- •History of or current circulatory disease (e.g., cerebrovascular or cardiovascular disease)
- •History of or current dry eye
- •Abnormal findings on OCT at screening or enrollment examination
- •Exclusion Criteria: Patients
- •Clinical findings or a history of conditions other than wAMD affecting the retina and choroid (e.g., diabetic retinopathy, diabetic macular edema, myopic CNV, retinal vein occlusion, or premacular membrane) in either of the eyes
- •Any of the following diseases in the study eye:
- •Ischemic optic neuropathy
- •Retinitis pigmentosa
- •Current or history of vitreous hemorrhage or macular hole in the study eye
- •Any abnormality in the anterior segment of the eye or vitreous body that may affect fundus observation by OCT, color fundus photography, or fluorescein angiography
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
KHK4951
Experimental
干预措施: KHK4951 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Day 1 to Day 43
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.
次要结局
- The maximum concentration(Day 1 to Day 43)
- Area under the concentration-time curve(Day 1 to Day 43)
- Serum KHK4951 concentration(Healthy Volunteers: Day 1, Day2, Day4, Day8, Day12, Day16, Day21, Day23, Day 25, Day 29, Day 36, Day 43; Patients: Day 1, 8, 22, 43)
- Time to the maximum concentration(Day 1 to Day 43)
- Apparent clearance(Day 1 to Day 43)
- Elimination half-life(Day 1 to Day 43)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Phase 1 Study of SKB571 in Subjects With Advanced Solid TumorsSolid MalignanciesNCT06725381Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.138
已完成
1 期
Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell DiseaseSickle Cell DiseaseNCT00842088HemaQuest Pharmaceuticals Inc.24
招募中
1 期
A Study for HSK39775 in Participants With Solid TumorsAdvanced Solid TumorsNCT06314373Xizang Haisco Pharmaceutical Co., Ltd243
已完成
1 期
Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic KeratosisActinic KeratosisNCT02337205Athenex, Inc.29
尚未招募
1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid TumorsSolid Tumor, AdultNCT05442996Shanghai Henlius Biotech30