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Drug Highest PhasePhase 2 |
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/ Active, not recruitingPhase 2 皮肤试验用结核分枝杆菌抗原(EM)用于3~17周岁、66~75周岁人群的安全性、耐受性与初步有效性的多中心、随机、双盲IIb期临床研究
[Translation] A multicenter, randomized, double-blind phase IIb clinical study on the safety, tolerability and preliminary efficacy of Mycobacterium tuberculosis antigen (EM) for skin testing in people aged 3 to 17 years and 66 to 75 years
主要目的：
1) 评价试验药物EM注射于3~17周岁呼吸道疾病患者（含结核病患者）和健康受试者、66~75周岁结核病患者和健康受试者中的安全性和耐受性；
2) 评价试验药物EM注射后，在3~17周岁、66~75周岁结核病患者中的灵敏度和在3~17周岁和66~75周岁健康受试者、3~17周岁非结核病其他呼吸道疾病患者中的特异度。
次要目的：
1) 观察试验药物EM注射后，迟发性超敏反应发生、发展与消失过程；
2) 评价试验药物EM与对照药品在3~17周岁、66~75周岁人群中皮试结果的一致性；
3) 评价试验药物EM与对照药品在3~17周岁、66~75周岁人群中与同用途IGRA结果的一致性；
4) 评价皮试前和皮试后IGRA结果的一致性。
[Translation] Main objectives:
1) To evaluate the safety and tolerability of the test drug EM injection in patients with respiratory diseases (including tuberculosis patients) aged 3-17 years and healthy subjects, and tuberculosis patients and healthy subjects aged 66-75 years;
2) To evaluate the sensitivity of the test drug EM injection in tuberculosis patients aged 3-17 years and 66-75 years, and the specificity in healthy subjects aged 3-17 years and 66-75 years, and patients with other respiratory diseases other than tuberculosis aged 3-17 years.
Secondary objectives:
1) To observe the occurrence, development and disappearance of delayed hypersensitivity reaction after the test drug EM injection;
2) To evaluate the consistency of the skin test results of the test drug EM and the control drug in the population aged 3-17 years and 66-75 years;
3) To evaluate the consistency of the test drug EM and the control drug with the same purpose IGRA results in the population aged 3-17 years and 66-75 years;
4) To evaluate the consistency of IGRA results before and after the skin test.
/ Active, not recruitingPhase 2 18~65周岁人群注射皮肤试验用结核分枝杆菌抗原(EM)的剂量探索、安全性和耐受性的多中心、随机、双盲IIa期临床研究
[Translation] A multicenter, randomized, double-blind phase IIa clinical study on the dose exploration, safety and tolerability of Mycobacterium tuberculosis antigen (EM) for skin testing in people aged 18 to 65 years old
主要目的：1)评价不同剂量EM注射后，变态反应原性在18~65周岁各类人群中的灵敏度（阳性符合率）和特异度（阴性符合率）；2)评价不同剂量EM注射于18~65周岁各类人群中的安全性和耐受性。
次要目的：1)确定IIb和III期临床研究最佳剂量，并初步确定阳性判定标准；2)评价不同剂量EM与已上市对照药品在18~65周岁各类人群中皮试结果的一致性；3)评价试验药物、对照药品与同用途IGRA结果的一致性。
探索性目的：评价试验用药品注射前后受试者体内特异性IgG抗体水平变化。
[Translation] Main objectives: 1) To evaluate the sensitivity (positive compliance rate) and specificity (negative compliance rate) of allergenicity in various populations aged 18 to 65 years after injection of different doses of EM; 2) To evaluate the safety and tolerability of different doses of EM in various populations aged 18 to 65 years.
Secondary objectives: 1) To determine the optimal dose for phase IIb and III clinical studies and preliminarily determine the positive judgment criteria; 2) To evaluate the consistency of skin test results between different doses of EM and marketed control drugs in various populations aged 18 to 65 years; 3) To evaluate the consistency of the results of the test drug, control drug and IGRA of the same use.
Exploratory objectives: To evaluate the changes in the level of specific IgG antibodies in the subjects before and after the injection of the test drug.
/ Active, not recruitingPhase 1 皮肤试验用结核分枝杆菌抗原(EM)用于结核病患者与健康受试者的安全性、耐受性与初步有效性的单中心、开放I期临床研究
[Translation] A single-center, open-label phase I clinical study on the safety, tolerability, and preliminary efficacy of Mycobacterium tuberculosis antigen (EM) for skin testing in tuberculosis patients and healthy subjects
主要目的：
结核病患者与健康受试者注射不同剂量EM的安全性与耐受性；结核病患者中不同浓度EM皮试检出阳性率，健康受试者中不同浓度EM皮试阴性符合率。
次要目的：
观察EM皮肤迟发性超敏反应发生、发展与消失过程；
为II期临床研究选择合适的剂量，将于3个剂量中选择2个剂量；
评估EM与同用途IGRA反应一致性；
II期和III期临床研究EM与EC反应结果不一致时需以IGRA进行第三种试剂验证，样品采样需在皮试后进行，本研究进行皮试前后取样检测，评估皮试后取样是否对IGRA检测结果产生影响。
[Translation] Main purpose:
Safety and tolerability of different doses of EM injected in tuberculosis patients and healthy subjects; positive rate of EM skin test at different concentrations in tuberculosis patients, and negative rate of EM skin test at different concentrations in healthy subjects.
Secondary purpose:
Observe the occurrence, development and disappearance of delayed hypersensitivity reaction of EM skin;
Select appropriate doses for phase II clinical study, and select 2 doses from 3 doses;
Evaluate the consistency of EM and IGRA reaction for the same purpose;
In phase II and phase III clinical studies, when the reaction results of EM and EC are inconsistent, IGRA needs to be used for third reagent verification, and sample sampling needs to be carried out after skin test. This study conducts sampling and testing before and after skin test to evaluate whether sampling after skin test affects the test results of IGRA.
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