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MechanismHyaluronic acid modulators |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
注射用重组人透明质酸酶在健康受试者中辅助皮下输液的药效学临床试验
[Translation] Clinical trial on the pharmacodynamics of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy subjects
主要目的:评价注射用重组人透明质酸酶在健康受试者中辅助皮下输液的药效学特征。
次要目的:评价注射用重组人透明质酸酶在健康受试者中的药效学特征、安全性、免疫原性。
[Translation] Primary objective: To evaluate the pharmacodynamic characteristics of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy subjects.
Secondary objective: To evaluate the pharmacodynamic characteristics, safety, and immunogenicity of recombinant human hyaluronidase for injection in healthy subjects.
注射用重组人透明质酸酶在中国健康受试者中辅助皮下输液的药效学研究
[Translation] Pharmacodynamic study of recombinant human hyaluronidase for injection as an adjunct to subcutaneous infusion in healthy Chinese subjects
主要目的:以皮下输液的速率为指标,评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的药效学特征;
次要目的:以受试者臂围的测量值为指标,评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的药效学特征;
评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的安全性和免疫原性。
[Translation] Primary purpose: To evaluate the pharmacodynamic characteristics of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects, using the rate of subcutaneous infusion as an indicator;
Secondary purpose: To evaluate the pharmacodynamic characteristics of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects, using the measured arm circumference of the subjects as an indicator;
Evaluate the safety and immunogenicity of a single self-controlled subcutaneous infusion of recombinant human hyaluronidase for injection in healthy subjects.
注射用重组人透明质酸酶在中国健康受试者中的单次给药的安全性、耐受性、药代动力学、免疫原性临床研究
[Translation] A clinical study on the safety, tolerability, pharmacokinetics and immunogenicity of a single dose of recombinant human hyaluronidase for injection in healthy Chinese subjects
主要目的: 评价注射用重组人透明质酸酶在健康受试者中单次给药的安全性和耐受性。 次要目的: 评价注射用重组人透明质酸酶在健康受试者中单次给药的药代动力学特征。 评价注射用重组人透明质酸酶在健康受试者中单次给药的免疫原性。
[Translation] Primary objective: To evaluate the safety and tolerability of a single dose of recombinant human hyaluronidase for injection in healthy subjects. Secondary objective: To evaluate the pharmacokinetic characteristics of a single dose of recombinant human hyaluronidase for injection in healthy subjects. To evaluate the immunogenicity of a single dose of recombinant human hyaluronidase for injection in healthy subjects.
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