评价 Volagidemab(REMD-477)在中国健康成年受试者中单次皮下给药后的
安全性、耐受性以及药代动力学的 I 期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of Volagidemab (REMD-477) after a single subcutaneous administration in healthy Chinese adult subjects
主要目的:
1) 评价中国健康成年受试者单次皮下注射 Volagidemab 的安全性和耐受性。
次要目的:
1) 评价中国健康成年受试者单次皮下注射 Volagidemab 后体内的药代动力学(PK)特征和药效学(PD)。
2) 探索中国健康成年受试者单次皮下注射 Volagidemab 后对肝功能的影响。
3) 评价中国健康成年受试者单次皮下注射 Volagidemab 后的免疫原性。
[Translation] Primary objectives:
1) To evaluate the safety and tolerability of a single subcutaneous injection of Volagidemab in healthy Chinese adult subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics and pharmacodynamics (PD) of Volagidemab in healthy Chinese adult subjects after a single subcutaneous injection.
2) To explore the effect of a single subcutaneous injection of Volagidemab on liver function in healthy Chinese adult subjects.
3) To evaluate the immunogenicity of Volagidemab in healthy Chinese adult subjects after a single subcutaneous injection.
100 Clinical Results associated with Beijing COSCI-REMD Biotherapeutics Co., Ltd.
0 Patents (Medical) associated with Beijing COSCI-REMD Biotherapeutics Co., Ltd.
100 Deals associated with Beijing COSCI-REMD Biotherapeutics Co., Ltd.
100 Translational Medicine associated with Beijing COSCI-REMD Biotherapeutics Co., Ltd.