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项与 卡介苗(安徽智飞龙科马生物) 相关的临床试验评价治疗用卡介苗用于预防18周岁及以上人群非肌层浸润性膀胱癌术后复发的安全性和耐受性的I期临床试验
主要目的:评价治疗用卡介苗用于预防18周岁及以上人群非肌层浸润性膀胱癌术后复发的安全性和耐受性,为后续Ⅲ期临床试验的开展提供数据支持。次要目的:(1)评价评价治疗用卡介苗在18周岁及以上非肌层浸润性膀胱癌经尿道切除术后患者中的药代动力学(PK)特征;(2)考察治疗用卡介苗在18周岁及以上非肌层浸润性膀胱癌经尿道切除术后患者体内的脱落情况和免疫应答特征。
随机、盲法、安慰剂对照评价皮内注射用卡介苗(BCG)在6-65岁人群中接种的安全性和人体耐受性的I期临床试验
主要目的: 评价试验用皮内注射用卡介苗在研究人群中应用的安全性和耐受性。 次要目的: 评价试验用皮内注射用卡介苗接种后机体84天、180天BCG-PPD、EC的阳转率。
Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG Vaccine for Intradermal Injection in 6-65 Year Olds
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design.
In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old .
The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects.
Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out.
100 项与 卡介苗(安徽智飞龙科马生物) 相关的临床结果
100 项与 卡介苗(安徽智飞龙科马生物) 相关的转化医学
100 项与 卡介苗(安徽智飞龙科马生物) 相关的专利(医药)
100 项与 卡介苗(安徽智飞龙科马生物) 相关的药物交易