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

NCT06711991 | Completed Phase 1

• 1 other identifier: TQC3927-I-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (11)

• Peak concentration (Cmax)

  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])

  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])

  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)

  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)

  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

Study Arms (2)

TQC3927 powder for inhalation

EXPERIMENTAL

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 powder for inhalation placebo

ACTIVE COMPARATOR

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

Interventions

TQC3927 powder for inhalation DRUG

TQC3927 is a targeted inhibitor

TQC3927 powder for inhalation

TQC3927 powder for inhalation placebo DRUG

A placebo without drug substance.

TQC3927 powder for inhalation placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (7)

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330038, China

Location

Heze Municipal Hospital

Heze, Shandong, 274031, China

Location

Zibo Municipal Hospital

Zibo, Shandong, 255400, China

Location

The Third People Hospital of Chengdu

Chengdu, Sichuan, 610031, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 2, 2024
• Study Start: February 11, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: August 15, 2025

Record last verified: 2024-11

Locations

CN (7)