[Translation] A randomized, open-label, single-dose, two-period, double-crossover, fasting and fed oral pharmacokinetic study of QHRD107 capsules in healthy Chinese subjects

主要目的：比较中国健康受试者空腹及餐后状态下单次口服QHRD107胶囊在体内的血药浓度及主要药代动力学参数，评价食物对QHRD107胶囊的影响。次要目的：评价中国健康受试者空腹和餐后状态下口服QHRD107胶囊的安全性。

[Translation]

Primary objective: To compare the blood drug concentration and main pharmacokinetic parameters of QHRD107 capsules in Chinese healthy subjects after a single oral administration in fasting and postprandial states, and to evaluate the effect of food on QHRD107 capsules. Secondary objective: To evaluate the safety of oral administration of QHRD107 capsules in Chinese healthy subjects in fasting and postprandial states.

Start Date13 Mar 2024

Sponsor / Collaborator

Changzhou Qianhong Biopharma Co., Ltd.

NCT06532058

/ Unknown statusPhase 2

Safety and Efficacy of QHRD107 Capsule Combined With Venclexta and Azacitidine in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: a Single-arm, Open, Multicenter Phase IIa Study

The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study

Start Date10 Aug 2023

Sponsor / Collaborator

Changzhou Qianhong Biopharma Co., Ltd.

CTR20190521

/ CompletedPhase 1

QHRD107胶囊治疗急性髓系白血病安全性的国内多中心、随机、开放、平行、剂量递增的I期临床研究

[Translation] A domestic multicenter, randomized, open, parallel, dose-escalating phase I clinical study on the safety of QHRD107 capsules in the treatment of acute myeloid leukemia

主要目的：观察口服不同剂量的QHRD107胶囊在急性髓系白血病患者中的安全性和耐受性，确定最大耐受剂量和剂量限制性毒性。次要目的：研究药物在体内的药物代谢动力学；初步考察药物对AML的疗效；初步确定有效剂量。探索性目的：探讨生物标志物Mcl-1 mRNA水平与AML发生发展的关系。

[Translation]

Primary purpose: To observe the safety and tolerability of oral QHRD107 capsules at different doses in patients with acute myeloid leukemia, and to determine the maximum tolerated dose and dose-limiting toxicity. Secondary purpose: To study the pharmacokinetics of the drug in vivo; To preliminarily investigate the efficacy of the drug on AML; To preliminarily determine the effective dose. Exploratory purpose: To explore the relationship between the biomarker Mcl-1 mRNA level and the occurrence and development of AML.

Start Date21 Nov 2019

Sponsor / Collaborator

Changzhou Qianhong Biopharma Co., Ltd.

100 Clinical Results associated with QHRD107

100 Translational Medicine associated with QHRD107

100 Patents (Medical) associated with QHRD107

100 Deals associated with QHRD107

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia with Myelodysplasia-Related Changes	Phase 2	China	Changzhou Qianhong Biopharma Co., Ltd.	10 Aug 2023
Relapsing acute myeloid leukemia	Phase 2	China	Changzhou Qianhong Biopharma Co., Ltd.	10 Aug 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


107VA REGIMEN (EHA2025)	Phase 2	Refractory acute myeloid leukemia	51	QHRD107	vwmqnlezzv(yfnqbtbhsg) = cvmklhgtkh chwwcojyyi (dxazzjbvgi, 6.0 - not reached) View more	Positive	14 May 2025
ASH2024	Not Applicable	Relapsing acute myeloid leukemia	-	QHRD107	urdvfjcaxw(bkhehpikkv) = jdsbcpncff vudvowjyxq (dpygtfyswu ) View more	-	08 Dec 2024

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