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Drug Highest PhasePhase 3 |
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Drug Highest PhasePhase 2 |
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/ Not yet recruitingPhase 2 3D1002联合盐酸羟考酮缓释片治疗中重度癌痛患者的多中心、随机的IIa/IIb期临床试验
[Translation] A multicenter, randomized phase IIa/IIb clinical trial of 3D1002 combined with oxycodone hydrochloride extended-release tablets for the treatment of moderate to severe cancer pain
IIa期通过评估3D1002 50、100、150 mg po q12h治疗中重度癌痛患者的有效性、安全性和药代动力学特征;IIb期通过首次研究药物治疗后14天的疼痛强度差异总和指标,比较3D1002联合盐酸羟考酮缓释片对比盐酸羟考酮缓释片单药治疗中重度癌痛患者的有效性、安全性,和评估3D1002和盐酸羟考酮缓释片的药物相互作用。
[Translation] Phase IIa evaluates the efficacy, safety, and pharmacokinetic characteristics of 3D1002 50, 100, and 150 mg po q12h in the treatment of patients with moderate to severe cancer pain. Phase IIb compares the efficacy and safety of 3D1002 combined with oxycodone hydrochloride extended-release tablets versus oxycodone hydrochloride extended-release tablets alone in the treatment of patients with moderate to severe cancer pain by studying the total pain intensity difference index 14 days after the first drug treatment, and evaluates the drug interaction between 3D1002 and oxycodone hydrochloride extended-release tablets.
3D-229联合紫杉醇对比安慰剂联合紫杉醇治疗铂耐药复发性卵巢癌的有效性与安全性的随机、双盲、对照、适应性III期研究
[Translation] A randomized, double-blind, controlled, adaptive phase III study of the efficacy and safety of 3D-229 combined with paclitaxel versus placebo combined with paclitaxel in the treatment of platinum-resistant recurrent ovarian cancer
主要目的:在铂耐药复发性卵巢癌受试者中,基于 RECIST 1.1 标准,评价 3D-229 联合 PAC (3D-229+PAC)vs.安慰剂和 PAC(安慰剂+PAC)对无进展生存期(PFS)的影响
次要目的:评价 3D-229+PAC 与安慰剂+PAC 对总生存期(OS)的影响
[Translation] Primary objective: To evaluate the effect of 3D-229 combined with PAC (3D-229+PAC) vs. placebo and PAC (placebo+PAC) on progression-free survival (PFS) in subjects with platinum-resistant recurrent ovarian cancer based on RECIST 1.1 criteria
Secondary objective: To evaluate the effect of 3D-229+PAC vs. placebo+PAC on overall survival (OS)
一项评价3D229静脉单次给药剂量递增和重复给药在健康受试者中安全性和耐受性的单盲、随机和安慰剂对照的I期研究
[Translation] A single-blind, randomized, placebo-controlled, phase I study to evaluate the safety and tolerability of single-ascending and repeated intravenous dosing of 3D229 in healthy subjects
单次给药剂量递增(SAD)队列
评价3D-229 在健康受试者中单次给药的安全性和耐受性。
重复给药(RD)队列
评价3D-229 RD在健康受试者中重复给药的安全性和耐受性。
[Translation] Single-dose escalation (SAD) cohort
Evaluate the safety and tolerability of a single dose of 3D-229 in healthy subjects.
Repeated-dose (RD) cohort
Evaluate the safety and tolerability of repeated doses of 3D-229 RD in healthy subjects.
100 Clinical Results associated with Xuzhou Thingdi Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Xuzhou Thingdi Pharmaceutical Co., Ltd.
100 Deals associated with Xuzhou Thingdi Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Xuzhou Thingdi Pharmaceutical Co., Ltd.