A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease

A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3927 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease

This project is the stage of dose escalation, is was divided into single and multiple dose clinical study, This is a multi-center, randomized, double-blind, placebo-controlled , study to the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in Chronic Obstructive Pulmonary Disease

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: TQC3927 powder for inhalation; Drug: TQC3927 powder for inhalation placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100049
      • Aerospace Center Hospital
    • Beijing, Beijing, China, 100000
      • China Japan Friendship Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • The First Affiliated Hospital of NanChang University
  • Shandong
    • Heze, Shandong, China, 274031
      • Heze Municipal Hospital
    • Zibo, Shandong, China, 255400
      • Zibo Municipal Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610031
      • The Third People Hospital of Chengdu
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between 18 and 45 years (inclusive)，both male and female
• The subjects were able to undergo reproducible FEV1 lung function testing according to the American Thoracic Society/European Respiratory Society (ATS/ERS) 2005 standard during screening
• Subject should weigh at least 45kg. And body mass index (BMI) within 18~30 kg/m2
• Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 90 days after the last dose (subjects and their partners)

Exclusion Criteria:

• Patients with a history of glaucoma, functional constipation, prostate hyperplasia, urinary tract obstruction, etc
• Individuals with a history of illegal drug abuse or who have tested positive for drug abuse screening during the screening period (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol)
• Participated in other clinical trials and received research interventions in the 3 months prior to participating in this trial
• Screening for individuals who have used biologics within the past 3 months
• Individuals who have lost blood or donated more than 400 mL of blood within 3 months prior to the experiment, or who have received blood transfusions or used blood products
• Any clear history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug
• Screening for individuals who have frequently consumed alcohol within the previous 6 months (i.e. females consume more than 14 standard units of alcohol per week, males consume more than 21 standard units of alcohol per week (1 standard unit contains 14g of alcohol, such as 360 mL beer or 45 mL of 40% alcohol strong liquor or 150 mL wine) or are unable to abstain from alcohol during the trial period; Or those who test positive for alcohol breath test
• History of any malignant tumors in organs or systems within the past 5 years, regardless of whether they have received treatment or not, except for local basal cell carcinoma of the skin
• When screening, the sitting systolic blood pressure should be ≥ 160 mmHg, and the sitting diastolic blood pressure should be ≥ 100 mmHg; Pulse rate<50 bpm or>100 bpm
• Clinically significant apnea patients requiring continuous positive airway pressure (CPAP) or non-invasive positive airway pressure (NIPPV) devices
• Those who require long-term oxygen therapy (oxygen therapy time>15 hours/day)
• Individuals who have undergone lobectomy or lung volume reduction surgery within the 12 months prior to the start of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQC3927 powder for inhalation; TQC3927 powder for inhalation is administered as a single administration for 1 day and continuous administration for 6 days.	Drug: TQC3927 powder for inhalation; TQC3927 is a targeted inhibitor
Active Comparator: TQC3927 powder for inhalation placebo; TQC3927 powder for inhalation placebo is administered as a single administration for 1 day and continuous administration for 6 days.	Drug: TQC3927 powder for inhalation placebo; A placebo without drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AE)	The occurrence of all adverse events (AE) including abnormal laboratory test indicators.	From the use of the investigational drug until the last study visit, up to day 16
Serious adverse events (SAE)	The occurrence of all serious adverse events (SAE) .	From the use of the investigational drug until the last study visit, up to day 16
Forced expiratory volume (FEV1) trough value changed from baseline	After administration of Day1 and Day7, the FEV1 trough value changed from baseline. The changes in FEV1 before administration of Day3 and Day5 compared to baseline.	After administration of Day1 and Day7，before administration of Day3 and Day5
Forced vital capacity (FVC) changes compared to baseline	FVC changes compared to baseline at each lung function visit point.	After administration of Day1 and Day7，before administration of Day3 and Day5
The peak FEV1 value changed from baseline	After administration of Day1 and Day7, the peak FEV1 value changed from baseline.	After administration of Day1 and Day7，before administration of Day3 and Day5
The area under the FEV1 curve of the average change from baseline	The area under the FEV1 curve of the average change from baseline after administration of D1 and D7 ranges from 0-6h (AUC0-6h), 0-12h (AUC0-12h), 12-24h (AUC12-24h), 0-24h (AUC0-24h), and FVC AUC (0-24h).	After administration of Day1 and Day7，before administration of Day3 and Day5
The change in chronic obstructive pulmonary disease (CAT) score from baseline	The change in chronic obstructive pulmonary disease (CAT) score from baseline on the day after Day7 administration.	After administration of Day1 and Day7，before administration of Day3 and Day5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	The Cmax is the maximum observed plasma concentration of study drug.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])	To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])	To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)	To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Half-life (t1/2)	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Apparent volume of distribution(Vd/F)	Apparent volume of distribution of the TQC3927 in plasma	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Apparent clearance (CLz/F)	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
End elimination rate (λz)	Derived from semi logarithmic linear regression of eliminating phase concentration points.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Residual area percentage (AUC_%Extrap)	Residual area percentage of the TQC3927 in plasma.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Average dwell time(MRT0-t)	The average residence time from 0:00 to the last measurable concentration time point.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose
Average dwell time(MRT0-∞)	Average residence time from 0:00 to infinity.	Day1: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24 hours after-dose, Day5: pre-dose, Day6: pre-dose, Day7: pre-dose, at 15,30,45 minutes,1,2,4,6,8,12,24,48,72 hours after-dose

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): August 11, 2025
• Study Completion (Actual): August 11, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TQC3927-I-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No