[Translation] A double-blind, single-dose, dose-escalation, placebo-controlled, sequential design trial with a pooled open-label, multiple-dose, parallel trial evaluating a single subcutaneous escalating dose of recombinant human albumin for injection-growth in healthy male subjects Phase I clinical trial of tolerability and safety following hormone fusion proteins.
主要目的: 评估健康男性受试者单次皮下注射递增剂量的注射用重组人血白蛋白-生长激素融合蛋白后的耐受性和安全性。 次要目的: 研究健康男性受试者单次皮下注射递增剂量的注射用重组人血白蛋白-生长激素融合蛋白后的药代动力学和药效学动力学; 比较健康男性受试者单次皮下注射注射用重组人血白蛋白-生长激素融合蛋白与多次皮下注射注射用重组人生长激素后的药代动力学和药效学动力学。
[Translation] Main objective: To evaluate the tolerability and safety of a single subcutaneous injection of escalating doses of recombinant human albumin-growth hormone fusion protein for injection in healthy male subjects. Secondary objectives: To study the pharmacokinetics and pharmacodynamics of a single subcutaneous injection of ascending doses of recombinant human albumin-growth hormone fusion protein for injection in healthy male subjects; to compare single doses of healthy male subjects Pharmacokinetics and pharmacodynamics after subcutaneous injection of recombinant human albumin-growth hormone fusion protein and multiple subcutaneous injections of recombinant human growth hormone for injection.