一项在中国和日本成年健康受试者中进行的Povetacicept随机、双盲、安慰剂对照、单次给药的剂量递增研究
[Translation] A randomized, double-blind, placebo-controlled, single-dose, dose-escalation study of Povetacicept in healthy adult subjects from China and Japan
1 主要目的
这项研究的主要目的是评价povetacicept在中国或日本健康成年受试者中的安全性和耐受性。
2 次要目的
本研究的次要目的为:
评估povetacicept的PK。
评估povetacicept的PD。
评估抗Povetacicept ADA的发生率。
[Translation] 1 Primary Objective
The primary objective of this study is to evaluate the safety and tolerability of povetacicept in healthy adult subjects from China or Japan.
2 Secondary Objectives
The secondary objectives of this study are:
To evaluate the PK of povetacicept.
To evaluate the PD of povetacicept.
To evaluate the incidence of anti-povetacicept ADA.
一项在难治性或不明原因慢性咳嗽成人受试者中进行BLU-5937开放性扩展治疗的III期、24周、随机、疗效和安全性研究
[Translation] A Phase III, 24-week, randomized, efficacy and safety study of BLU-5937 in an open-label, extended-treatment setting in adult subjects with refractory or unexplained chronic cough
主要目的:评估BLU-5937与安慰剂相比在基线24小时咳嗽频率≥8次咳嗽/小时的RCC(包括不明原因的慢性咳嗽)成人患者中对第24周时24小时咳嗽频率的影响以及确定截至第24周时BLU-5937与安慰剂相比在RCC(包括不明原因的慢性咳嗽)成人患者中的安全性 次要目的:评价BLU-5937对咳嗽频率和PRO等其他指标的影响 探索性目的:评价BLU-5937对咳嗽频率和PRO等其他指标的影响
[Translation] Primary Objectives: To evaluate the effect of BLU-5937 on 24-hour cough frequency at Week 24 compared to placebo in adult patients with RCC (including chronic cough of unknown etiology) with a baseline 24-hour cough frequency ≥8 coughs/hour and to determine the safety of BLU-5937 compared to placebo in adult patients with RCC (including chronic cough of unknown etiology) as of Week 24 Secondary Objectives: To evaluate the effect of BLU-5937 on other measures, including cough frequency and PROs Exploratory Objectives: To evaluate the effect of BLU-5937 on other measures, including cough frequency and PROs
China Kidney Patient Trials Network
This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.
100 Clinical Results associated with George (Beijing) Clinical Research Co., Ltd.
0 Patents (Medical) associated with George (Beijing) Clinical Research Co., Ltd.
100 Deals associated with George (Beijing) Clinical Research Co., Ltd.
100 Translational Medicine associated with George (Beijing) Clinical Research Co., Ltd.