A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetic Characteristics of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is anticipated that 256 subjects will be enrolled.

Start Date01 Apr 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT06449859

/ Active, not recruitingPhase 1

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TQC2938 Injection in Healthy Adult Subjects After Single and Multiple Administration

The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults.

Start Date13 Jun 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20252117

/ Not yet recruitingPhase 2

评价TQC2938注射液联合背景治疗在季节性过敏性鼻炎患者中的有效性与安全性的随机、双盲、安慰剂对照、多中心II期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of TQC2938 injection combined with background treatment in patients with seasonal allergic rhinitis

主要目的评价TQC2938注射液在背景治疗下治疗季节性过敏性鼻炎（SAR）患者的有效性。次要目的评价TQC2938注射液在背景治疗下治疗SAR患者的安全性；评价TQC2938注射液在背景治疗下治疗SAR患者的药代动力学（PK）特征；评价TQC2938注射液在背景治疗下治疗SAR患者的药效动力学（PD）特征；评价TQC2938注射液在背景治疗下治疗SAR患者的免疫原性。探索性目的探讨TQC2938在SAR合并哮喘患者亚组中的作用；探索性分析与TQC2938注射液相关性的疗效标志物

[Translation]

Primary objective To evaluate the effectiveness of TQC2938 injection in the treatment of patients with seasonal allergic rhinitis (SAR) under background treatment. Secondary objective To evaluate the safety of TQC2938 injection in the treatment of SAR patients under background treatment; To evaluate the pharmacokinetic (PK) characteristics of TQC2938 injection in the treatment of SAR patients under background treatment; To evaluate the pharmacodynamic (PD) characteristics of TQC2938 injection in the treatment of SAR patients under background treatment; To evaluate the immunogenicity of TQC2938 injection in the treatment of SAR patients under background treatment. Exploratory objective To explore the role of TQC2938 in the subgroup of patients with SAR and asthma; To explore the efficacy markers associated with TQC2938 injection

Start Date-

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with TQC2938

100 Translational Medicine associated with TQC2938

100 Patents (Medical) associated with TQC2938

100 Deals associated with TQC2938

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2025
Pulmonary Disease, Chronic Obstructive	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Apr 2025
Asthma	Phase 1	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	13 Jun 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2025	Phase 1	-	44	TQC2938 210 mg (IV)	gxljsrwnaq(rmobncioiq) = All the adverse events (AE) reported were of grade 1 or 2 gukcxpgsug (yyqgcwppoj ) View more	Positive	16 May 2025
				TQC2938 210 mg (SC)

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