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临床试验/NCT07302945
NCT07302945已完成1 期

High-Resolution Immune Dynamics Following OTS-412 Oncolytic Vaccinia Virus Administration in a Healthy Volunteer(Self-experiment)

Bionoxx Inc.1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年1月4日最近更新:
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Changes in ANC(absolute neutrophil count) over time

研究概览

简要总结

Following oncolytic virus (OV) administration, the host immune response is initiated immediately and evolves dynamically. However, in clinical OV therapy, it is virtually impossible to capture these immune events in real time. To address this gap, the principal investigator conducted a high-resolution immune monitoring study in a healthy volunteer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • A healthy adult

排除标准

  • 未提供

研究组 & 干预措施

OV Treated healthy arm

Experimental

干预措施: OTS-412 (Biological)

结局指标

主要结局

Changes in ANC(absolute neutrophil count) over time

时间窗: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

Changes in lymphocytes count over time

时间窗: 4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16

次要结局

  • FLow cytometry(4 hour, 8 hour, 20 hour, 24 hour, Day 2, Day 5, Day 8, Day 16)

研究者

发起方
Bionoxx Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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