This is a single-center, randomized, open, six-sequence, three-period crossover phase I clinical trial in healthy subjects to compare the PK/PD and safety profiles of single dose of HR20014, INS068, and INS062. In this study, 12 subjects were randomly assigned to 6 administration sequences in a ratio of 1:1:1:1:1:1, and HR20014, INS068 or INS062 injection were given subcutaneously three times before and after each sequence.

Start Date23 May 2023

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

CTR20231288 / CompletedPhase 1

比较健康受试者单次皮下注射HR20014、INS068和INS062注射液的药代动力学和药效动力学特征–单中心、随机、开放、六序列、三周期交叉设计

[Translation] Comparison of the pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous injection of HR20014, INS068, and INS062 in healthy subjects – a single-center, randomized, open-label, six-sequence, three-period crossover design

主要研究目的：比较单次皮下注射HR20014和INS068的PD特征（基于AUCGIR, 0-6h）；比较单次皮下注射HR20014和INS062的PD特征（基于AUCGIR, 6-24h）。

[Translation]

Main research objectives: To compare the PD characteristics of a single subcutaneous injection of HR20014 and INS068 (based on AUCGIR, 0-6h); to compare the PD characteristics of a single subcutaneous injection of HR20014 and INS062 (based on AUCGIR, 6-24h).

Start Date23 May 2023

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

CTR20230178 / Active, not recruitingPhase 3

一项在口服降糖药治疗血糖控制不佳的2型糖尿病患者中，比较INS068注射液和甘精胰岛素的有效性和安全性的随机、开放、平行对照的多中心临床研究

[Translation] A randomized, open-label, parallel-controlled, multicenter clinical study comparing the efficacy and safety of INS068 injection and insulin glargine in patients with type 2 diabetes who have poor blood sugar control with oral hypoglycemic drugs

在口服降糖药治疗血糖控制不佳的2型糖尿病患者中，比较INS068和甘精胰岛素治疗26周后的有效性和安全性。

[Translation]

To compare the efficacy and safety of INS068 and insulin glargine after 26 weeks of treatment in patients with type 2 diabetes who are inadequately controlled on oral hypoglycemic agents.

Start Date31 Mar 2023

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with INS-068

100 Translational Medicine associated with INS-068

100 Patents (Medical) associated with INS-068

Literatures (Medical) associated with INS-068

Frontiers in Pharmacology

Pharmacokinetics and bioavailability of a new long-acting insulin analog in healthy Chinese volunteers: an open, randomized, single-dose, two-period and two-sequence cross-over study

Article

Author: Song, Lin-Lin ; Ye, Pan-Pan ; Shen, Kai ; Yang, Xin-Mei ; Zhao, Fu-Rong ; Zhao, Wei ; Chen, Ke-Guang ; Feng, Sheng ; Gao, Xue-Hu ; Shi, Jin-Yi ; Li, Qian ; Zhou, Hai-Yan ; Zhang, Ye-Hui

Objectives:INS068 is a novel, soluble, and long-acting insulin analog. In this study, we evaluated the pharmacokinetics and relative bioavailability of two formulations of INS068 in healthy Chinese subjects: a reference formulation packaged in vials and administered via syringe (R), and a test formulation packaged and administered via pen injector (T).Methods:A randomized, open-label, two-period, two-sequence crossover study was conducted with 24 healthy Chinese subjects. Subjects were randomized and administered subcutaneously in the abdomen at 0.4 U/kg of test or reference INS068 injection according to an open crossover design. INS068 concentrations in the serum were measured using LC-MS/MS, and the pharmacokinetic parameters of maximum concentration (Cmax) and area under the concentration-time curve (AUC0–tand AUC0–∞) were used to evaluate relative bioavailability.Results:After a single dose at 0.4 U/kg, the median Tmaxof INS068 was 12 h for both formulations, and the mean t1/2for T and R was 13.0 h and 12.6 h, respectively. The geometric means of Cmaxand AUC0–∞were 3.99 nmol/L and 120 h·nmol/L for the T, and 4.05 nmol/L and 117 h·nmol/L for the R, respectively. The geometric mean ratios of Cmax, AUC0–tand AUC0–∞of T over R were 98.7% (90% CI: 92.7%–105.2%), 102.6% (90% CI: 100.0%–105.3%) and 102.8% (90% CI: 100.1%–105.5%).Conclusion:The overall PK profile of the two formulations of INS068 injection was comparable in healthy subjects, and the pen injector of INS068 had adequate safety and tolerability, supporting it as a new formulation in a phase III study and bridging PK data from early phase clinical trials.Clinical Trial Registration:clinicaltrials.gov, identifier: NCT05336071

100 Deals associated with INS-068

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Mar 2023
Diabetes Mellitus	Phase 2	-	Luzsana Biotechnology, Inc.	18 May 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05333835 (ADA2024) Manual	Phase 2	Diabetes Mellitus, Type 2	455	HR17031	(vxufamnmet) = iailqhufct urvlgcufrp (dyndblgbmc ) View more	Positive	21 Jun 2024
				INS068	(vxufamnmet) = qmrzxexwyt urvlgcufrp (dyndblgbmc ) View more
751-P (ADA2024)	Phase 2	Diabetes Mellitus, Type 2	455	HR17031	ippekatgdw(zgoqnbrsjm) = zhvtquaubz owingpjmlm (ardckytrmc ) View more	Positive	14 Jun 2024
				INS068	ippekatgdw(zgoqnbrsjm) = ffaaucekpx owingpjmlm (ardckytrmc ) View more

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