[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects
主要目的:
研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后的安全性和耐受性,确定安全剂量的范围。
次要目的:
1. 研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后活性成分 rACTH 的药代动力学(Pharmacokinetics,PK)特征。
2. 研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后的药效学(Pharmacodynamics, PD)特征。
[Translation] Primary objective:
To study the safety and tolerability of single and multiple intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects and to determine the safe dose range.
Secondary objectives:
1. To study the pharmacokinetic (PK) characteristics of the active ingredient rACTH after single and multiple intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects.
2. To study the pharmacodynamic (PD) characteristics of recombinant corticotropin for injection in healthy Chinese subjects after single and multiple intramuscular administration.