临床试验/NCT03769454

NCT03769454已完成1 期

A Phase I Safety and Tolerability Study of PP-001 Eye Drops in Healthy Adult Volunteers

Panoptes Pharma GmbH1 个研究点分布在 1 个国家目标入组 45 人开始时间: 2018年11月20日最近更新: 2024年1月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Panoptes Pharma GmbH
入组人数: 45
试验地点: 1
主要终点: Evaluation of safety and tolerability by determining treatment emergent adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study, PP-001 eye drops are assessed for safety and tolerability in healthy, adult volunteers. PP-001 is a novel, anti-inflammatory small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase).

The study was amended and now includes patients with ocular surface inflammation.

详细描述

In this prospective, single-centre, double blind (within each cohort), placebo controlled, randomised study, safety and tolerability of PP-001 eye drops is assessed in healthy, adult volunteers (cohorts 1-3) and in patients with ocular surface inflammation (cohort 4). PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with anti-inflammatory properties.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

PP-001 verum - cohort 1

Experimental

PP-001 verum - cohort 1

干预措施: PP-001 (Drug)

Placebo - cohort 1

Placebo Comparator

Placebo - cohort 1

干预措施: Placebo (Other)

PP-001 verum - cohort 2

Experimental

PP-001 verum - cohort 2

干预措施: PP-001 (Drug)

Placebo - cohort 2

Placebo Comparator

Placebo - cohort 2

干预措施: Placebo (Other)

PP-001 verum - cohort 3

Experimental

PP-001 verum - cohort 3

干预措施: PP-001 (Drug)

Placebo - cohort 3

Placebo Comparator

Placebo - cohort 3

干预措施: Placebo (Other)

PP-001 verum - cohort 4

Experimental

PP-001 verum - cohort 4

干预措施: PP-001 (Drug)

Placebo - cohort 4

Placebo Comparator

Placebo - cohort 4

干预措施: Placebo (Other)

结局指标

主要结局

Evaluation of safety and tolerability by determining treatment emergent adverse events

时间窗: 28 days (cohorts 1-3) and 20 days (cohort 4)

To assess safety and tolerability of ascending, multiple daily doses of PP-001 eye drops in healthy, adult volunteers and in patients with ocular surface inflammation

次要结局

Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood(1 and 12 days (cohorts 1-3))
Evaluation of area under the plasma concentration versus time curve (AUC) in peripheral blood(1 and 12 days (cohorts 1-3))

研究者

发起方

Panoptes Pharma GmbH

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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