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Drug Highest PhasePhase 3 |
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一项在健康受试者中评价TG103注射液对缬沙坦胶囊、华法林钠片、阿托伐他汀钙片和地高辛片的药代动力学影响的I期临床试验
[Translation] A Phase I clinical trial evaluating the effect of TG103 injection on the pharmacokinetics of valsartan capsules, warfarin sodium tablets, atorvastatin calcium tablets, and digoxin tablets in healthy subjects
主要目的:
队列1:在中国健康受试者中评价TG103注射液对缬沙坦胶囊和华法林钠片的药代动力学(Pharmacokinetics,PK)影响。
队列2:在中国健康受试者中评价TG103注射液对阿托伐他汀钙片和地高辛片的PK影响。
次要目的:
队列1:在中国健康受试者中评价TG103注射液多次给药的PK特征和免疫原性;评价TG103注射液对华法林钠片药效动力学(Pharmacodynamics,PD)的影响;TG103注射液、缬沙坦胶囊和华法林钠片的安全性和耐受性;初步探索中国健康受试者中TG103注射液对QTc间期的影响。
队列2:在中国健康受试者中评价TG103注射液多次给药的PK特征和免疫原性;评价TG103注射液、阿托伐他汀钙片和地高辛片的安全性和耐受性。
[Translation] Primary objectives:
Cohort 1: To evaluate the effect of TG103 injection on the pharmacokinetics (PK) of valsartan capsules and warfarin sodium tablets in healthy Chinese subjects.
Cohort 2: To evaluate the effect of TG103 injection on the PK of atorvastatin calcium tablets and digoxin tablets in healthy Chinese subjects.
Secondary objectives:
Cohort 1: To evaluate the PK characteristics and immunogenicity of TG103 injection after multiple administration in healthy Chinese subjects; to evaluate the effect of TG103 injection on the pharmacodynamics (PD) of warfarin sodium tablets; the safety and tolerability of TG103 injection, valsartan capsules and warfarin sodium tablets; to preliminarily explore the effect of TG103 injection on the QTc interval in healthy Chinese subjects.
Cohort 2: To evaluate the PK characteristics and immunogenicity of TG103 injection after multiple administration in healthy Chinese subjects; to evaluate the safety and tolerability of TG103 injection, atorvastatin calcium tablets and digoxin tablets.
一项多中心、非随机、开放、平行对照、单次给药,评价TG103注射液在肾功能正常和肾功能不全受试者中的药代动力学特征的Ⅰ期临床试验
[Translation] A multicenter, non-randomized, open-label, parallel-controlled, single-dose phase I clinical trial to evaluate the pharmacokinetic characteristics of TG103 injection in subjects with normal renal function and renal insufficiency
主要目的:
评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的药代动力学特征。
次要目的:
评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的免疫原性; 评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的安全性和耐受性。
[Translation] Primary purpose:
To evaluate the pharmacokinetic characteristics of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency.
Secondary purpose:
To evaluate the immunogenicity of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency; To evaluate the safety and tolerability of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency.
/ Active, not recruitingPhase 3 TG103注射液联合二甲双胍治疗2型糖尿病患者的多中心、随机、开放、度拉糖肽对照的Ⅲ期临床试验
[Translation] A multicenter, randomized, open-label, dulaglutide-controlled phase III clinical trial of TG103 injection combined with metformin in the treatment of patients with type 2 diabetes
主要研究目的:
在经二甲双胍单药治疗血糖控制不佳的2型糖尿病患者中,分别评估TG103 注射液7.5mg及15mg每周一次联合二甲双胍治疗28周HbA1c较基线变化非劣效于度拉糖肽
次要研究目的:
1. 在经二甲双胍单药治疗后血糖控制不佳的2型糖尿病患者中,分别评估TG103注射液7.5mg及15mg每周一次联合二甲双胍治疗52周HbA1c较基线变化非劣效于度拉糖肽;
2. 在经二甲双胍单药治疗血糖控制不佳的2型糖尿病患者中,评估TG103注射液联合二甲双胍的安全性;
3. 评估不同剂量给药TG103注射液在2型糖尿病受试者中的药代动力学(PK)特征;
4. 评估TG103注射液的免疫原性。
[Translation] Main study objectives:
In patients with type 2 diabetes who have poor glycemic control on metformin monotherapy, to evaluate the non-inferiority of TG103 injection 7.5mg and 15mg once weekly combined with metformin for 28 weeks in terms of HbA1c change from baseline to dulaglutide
Secondary study objectives:
1. In patients with type 2 diabetes who have poor glycemic control on metformin monotherapy, to evaluate the non-inferiority of TG103 injection 7.5mg and 15mg once weekly combined with metformin for 52 weeks in terms of HbA1c change from baseline to dulaglutide;
2. In patients with type 2 diabetes who have poor glycemic control on metformin monotherapy, to evaluate the safety of TG103 injection combined with metformin;
3. To evaluate the pharmacokinetic (PK) characteristics of TG103 injection at different doses in subjects with type 2 diabetes;
4. To evaluate the immunogenicity of TG103 injection.
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