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非在研适应症- |
最高研发阶段申请上市 |
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非在研适应症- |
最高研发阶段临床3期 |
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非在研适应症- |
最高研发阶段临床2期 |
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评价司美格鲁肽注射液与原研司美格鲁肽注射液在中国肥胖受试者中安全性和有效性的多中心、随机、开放、平行对照的III期临床研究
在减少饮食热量摄入和增加体力活动基础上,评价采用试验药物司美格鲁肽注射液与对照药品原研司美格鲁肽注射液治疗44周后,在中国肥胖非糖尿病受试者中减重的等效性。
比较司美格鲁肽注射液与诺和泰®注射液在健康受试者中药代动力学相似性、安全性和免疫原性的随机、开放、单剂量、平行对照的I期临床研究
评价在健康成年受试者中单次皮下注射杭州中美华东制药江东有限公司生产的司美格鲁肽注射液和丹麦诺和诺德公司生产的诺和泰®注射液的AUC0-inf、AUC0-t和Cmax的相似性。
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients with Short Bowel Syndrome Requiring Parenteral Nutrition
The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are:
* How effective is PJ009 in treating short bowel syndrome?
* Is PJ009 safe in these patients? Researchers will compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS.
Participants will
* Receive daily subcutaneous injections of PJ009 or placebo according to weight for 24 weeks, and then the participants receive placebo will be switched to receive PJ009 for another 12 weeks, while participants receive PJ009 continued the same treatment until the end of 36 weeks,
* Visit the clinic at the end of week 1(w1), w2, w4, w8, w12, w16, w20, w24, w30 and w36 for assessment,
* Keep a diary of the amount of their parenteral nutrition/ intravenous fluids (PN/IV), enteral nutrition and urine volume.
100 项与 重庆派金生物科技有限公司 相关的临床结果
0 项与 重庆派金生物科技有限公司 相关的专利(医药)
100 项与 重庆派金生物科技有限公司 相关的药物交易
100 项与 重庆派金生物科技有限公司 相关的转化医学