ACTRN12621000351819已完成1 期
A Phase 1, Multi-Center, Open-Label, Single-Dose, Parallel-Arm Study to Assess the Minimum Effective Concentration of NVK031 on Pupillary Constriction and Distance Vision in Healthy Volunteers
evakar, Inc.0 个研究点目标入组 36 人开始时间: 2021年3月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Age greater than or equal to 18 to less than or equal to 55 years
- •2. Subjects must be in good general health, with no significant medical problems that, in the
- •opinion of the investigator, would preclude participation in the trial, at Screening and/or
- •before administration of NVK031
- •3. Photopic high-contrast CCVA better than or equal to 20/25 in both eyes at Screening
- •4. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at
- •5. Nature of the study has been explained and prior to the commencement of any study procedures
排除标准
- •1. History of any corneal abnormality (e.g., keratoconus, pellucid marginal degeneration,
- •corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that is likely to
- •interfere with visual acuity
- •2. Serious systemic illness that, in the opinion of the Investigator’s, would render the subject
- •3. Pre-planned hospitalization or ocular or systemic surgery during the study period
- •4. Present history of any substance abuse (alcohol and/or illegal drugs)
- •5. Participation in any other study of investigational therapy during the study period or within
- •the last 30 days or 5 half-lives, whichever is longer
- •6. Unwilling or unable to complete study procedures or to be followed up for the duration of the study
研究者
相似试验
进行中（未招募）
1 期
A Phase I/II Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease.Fabry Disease (X-linked lysosomal storage disease).MedDRA version: 24.1Level: PTClassification code: 10016016Term: Fabry´s disease Class: 100000004850CTIS2024-512695-34-00Sangamo Therapeutics Inc.46
进行中（未招募）
1 期
A Phase I/II Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry DiseaseFabry Disease (X-linked lysosomal storage disease)MedDRA version: 20.0Level: PTClassification code 10016016Term: Fabry's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2019-000667-24-ITSangamo Therapeutics, Inc.48
进行中（未招募）
1 期
A Phase I/II Study to Assess the Safety and Tolerability of ST-920, a rAAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry DiseaseFabry Disease (X-linked lysosomal storage disease)MedDRA version: 20.0 Level: PT Classification code 10016016 Term: Fabry's disease System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2019-000667-24-GBSangamo Therapeutics, Inc.30
进行中（未招募）
1 期
A Phase I/II Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry DiseaseFabry Disease (X-linked lysosomal storage disease)MedDRA version: 24.1Level: PTClassification code 10016016Term: Fabry's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2019-000667-24-DESangamo Therapeutics, Inc.48
已完成
不适用
A Phase 1, open-label, single-dose, single-center, mass balance study of IPN60130 following a single 60-mg oral dose of IPN60130 containing 9 µCi of [14C]-IPN60130 in healthy male participantsNL-OMON50811Ipsen Pharmaceuticals6