GCGR agonists(Glucagon receptor agonists), GIPR agonists(Gastric inhibitory polypeptide receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseDigestive System DisordersUrogenital Diseases

Active Indication

Diabetes Mellitus, Type 2Nonalcoholic SteatohepatitisObesity+ [1]

Inactive Indication-

Originator Organization

Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.

Active Organization

Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Clinical Trials associated with UBT-251

CTR20233938

/ Not yet recruitingPhase 1

评估超重/肥胖患者多次皮下注射UBT251的安全性、耐受性、药代动力学、药效动力学的Ⅰ期临床试验

[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of UBT251 in overweight/obese patients

主要目的：评价超重/肥胖受试者多次皮下注射UBT251的安全性和耐受性（包含局部耐受性）。次要目的：评价超重/肥胖受试者多次皮下注射UBT251注射液后的PK/PD特征；评价超重/肥胖受试者多次皮下注射UBT251注射液后的初步疗效；评价超重/肥胖受试者多次皮下注射UBT251注射液后的免疫原性。探索性目的：探索超重/肥胖受试者多次皮下注射UBT251注射液后对食欲的影响；探索超重/肥胖受试者多次皮下注射UBT251注射液对QT/QTc间期的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability (including local tolerance) of multiple subcutaneous injections of UBT251 in overweight/obese subjects. Secondary objectives: To evaluate the PK/PD characteristics of overweight/obese subjects after multiple subcutaneous injections of UBT251 injection; To evaluate the preliminary efficacy of overweight/obese subjects after multiple subcutaneous injections of UBT251 injection; To evaluate the immunogenicity of overweight/obese subjects after multiple subcutaneous injections of UBT251 injection. Exploratory objectives: To explore the effect of multiple subcutaneous injections of UBT251 injection on appetite in overweight/obese subjects; To explore the effect of multiple subcutaneous injections of UBT251 injection on QT/QTc interval in overweight/obese subjects.

Start Date-

Sponsor / Collaborator

Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.

CTR20234009

/ Not yet recruitingPhase 1

评估成人2型糖尿病患者多次皮下注射UBT251的安全性、耐受性、药代动力学、药效动力学的Ⅰ期临床试验

[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of UBT251 in adults with type 2 diabetes

主要目的：评价2型糖尿病患者多次皮下注射UBT251的安全性和耐受性（包含局部耐受性）。次要目的：评价2型糖尿病患者多次皮下注射UBT251注射液后的PK/PD特征；评价2型糖尿病患者多次皮下注射UBT251注射液后的初步疗效；评价2型糖尿病患者多次皮下注射UBT251注射液后的免疫原性。探索性目的：探索2型糖尿病患者多次皮下注射UBT251注射液对QT/QTc间期的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability (including local tolerance) of multiple subcutaneous injections of UBT251 in patients with type 2 diabetes. Secondary objective: To evaluate the PK/PD characteristics of multiple subcutaneous injections of UBT251 injection in patients with type 2 diabetes; To evaluate the preliminary efficacy of multiple subcutaneous injections of UBT251 injection in patients with type 2 diabetes; To evaluate the immunogenicity of multiple subcutaneous injections of UBT251 injection in patients with type 2 diabetes. Exploratory objective: To explore the effect of multiple subcutaneous injections of UBT251 injection on the QT/QTc interval in patients with type 2 diabetes.

Start Date-

Sponsor / Collaborator

Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.

CTR20232997

/ RecruitingPhase 1

评估健康受试者单次皮下注射UBT251的安全性、耐受性、药代动力学、药效动力学的Ⅰ期临床试验

[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of UBT251 in healthy subjects

主要目的：评价健康受试者单次皮下注射UBT251注射液的安全性和耐受性（包含局部耐受性）。次要目的：评价健康受试者单次皮下注射UBT251 注射液的药代动力学（Pharmacokinetics，PK）/药效动力学（Pharmacodynamics，PD）特征；评价健康受试者单次皮下注射UBT251注射液的免疫原性特征。

[Translation]

Primary objective: To evaluate the safety and tolerability (including local tolerance) of a single subcutaneous injection of UBT251 injection in healthy subjects. Secondary objective: To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of a single subcutaneous injection of UBT251 injection in healthy subjects; To evaluate the immunogenicity characteristics of a single subcutaneous injection of UBT251 injection in healthy subjects.

Start Date10 Oct 2023

Sponsor / Collaborator

Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.

100 Clinical Results associated with UBT-251

100 Translational Medicine associated with UBT-251

100 Patents (Medical) associated with UBT-251

100 Deals associated with UBT-251

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	CN	Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.	13 Jan 2025
Nonalcoholic Steatohepatitis	Phase 1	CN	Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.	10 Oct 2023
Obesity	Phase 1	CN	Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.	10 Oct 2023
Chronic Kidney Diseases	IND Approval	CN	Federal Biotechnology (Zhuhai Hengqin) Co., Ltd.	20 Jan 2025

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