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MechanismBacterial DNA gyrase inhibitors [+1] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date20 Dec 1996 |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
抗PD-1人源化单抗hAB21注射液治疗晚期恶性实体瘤患者的耐受性、安全性和药代动力学I 期临床研究
[Translation] Phase I clinical study on the tolerability, safety and pharmacokinetics of anti-PD-1 humanized monoclonal antibody hAB21 injection in patients with advanced malignant solid tumors
试验主要目的:评价单药hAB21注射液、hAB21注射液& hPV19注射液治疗晚期恶性实体瘤患者的耐受性、安全性; 评估hAB21注射液给药的剂量限制性毒性(DLT)、最大耐受剂量(MTD),用于II期试验的推荐剂量 次要目的:评价hAB21注射液、hAB21注射液& hPV19注射液药代动力学(PK)及免疫原性(ADA)特征; 评价hAB21注射液、hAB21注射液& hPV19注射液临床有效性;探索hAB21注射液药效学特征
[Translation] The main purpose of the trial is to evaluate the tolerability and safety of single-agent hAB21 injection, hAB21 injection & hPV19 injection in the treatment of patients with advanced malignant solid tumors; to assess the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of hAB21 injection, and the recommended dose for Phase II trials. Secondary objectives are to evaluate the pharmacokinetic (PK) and immunogenicity (ADA) characteristics of hAB21 injection, hAB21 injection & hPV19 injection; to evaluate the clinical effectiveness of hAB21 injection, hAB21 injection & hPV19 injection; to explore the pharmacodynamic characteristics of hAB21 injection.
抗VEGF单抗苏洛晍SOLOT-Eye 治疗新生血管性年龄相关性黄斑变性(湿性AMD)患者的安全性、耐受性和初步疗效的I期临床试验
[Translation] A phase I clinical trial to evaluate the safety, tolerability and preliminary efficacy of the anti-VEGF monoclonal antibody SOLOT-Eye in the treatment of patients with neovascular age-related macular degeneration (wet AMD)
观察人体对不同剂量组的苏洛晍眼用注射液(hPV19单抗眼用注射液)不良反应和不良反应特征,并观察在设定剂量组中可能出现的最大耐受剂量(MTD),以及剂量限制性毒性(DLT)
[Translation] To observe the adverse reactions and adverse reaction characteristics of human body to different dose groups of Suloxue ophthalmic injection (hPV19 monoclonal antibody ophthalmic injection), and to observe the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) that may occur in the set dose groups
人源化hPV19单克隆抗体注射液治疗晚期恶性实体瘤患者的耐受性、安全性和药代动力学 I 期临床研究
[Translation] Phase I clinical study on the tolerability, safety and pharmacokinetics of humanized hPV19 monoclonal antibody injection in the treatment of patients with advanced malignant solid tumors
观察人源化hPV19单克隆抗体注射液单次及多次给药的耐受性、安全性以及药代动力学;探索本药在人体的MTD。
[Translation] Observe the tolerability, safety, and pharmacokinetics of single and multiple administrations of humanized hPV19 monoclonal antibody injection; explore the MTD of this drug in humans.
100 Clinical Results associated with Suzhou Stainwei Biotechnology Co., Ltd.
0 Patents (Medical) associated with Suzhou Stainwei Biotechnology Co., Ltd.
100 Deals associated with Suzhou Stainwei Biotechnology Co., Ltd.
100 Translational Medicine associated with Suzhou Stainwei Biotechnology Co., Ltd.