Clinical trial NCT06711991: A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events (AE)
timeFrame: From the use of the investigational drug until the last study visit, up to day 16
measure: Serious adverse events (SAE)
timeFrame: From the use of the investigational drug until the last study visit, up to day 16
measure: Forced expiratory volume (FEV1) trough value changed from baseline
timeFrame: After administration of Day1 and Day7，before administration of Day3 and Day5
measure: Forced vital capacity (FVC) changes compared to baseline
timeFrame: After administration of Day1 and Day7，before administration of Day3 and Day5
measure: The peak FEV1 value changed from baseline
timeFrame: After administration of Day1 and Day7，before administration of Day3 and Day5
measure: The area under the FEV1 curve of the average change from baseline
timeFrame: After administration of Day1 and Day7，before administration of Day3 and Day5
measure: The change in chronic obstructive pulmonary disease (CAT) score from baseline
timeFrame: After administration of Day1 and Day7，before administration of Day3 and Day5
Secondary outcomes:
measure: Peak concentration (Cmax)
timeFrame: 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
measure: Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
timeFrame: 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
measure: Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
timeFrame: 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
measure: Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
timeFrame: 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
measure: Half-life (t1/2)
timeFrame: 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
measure: Apparent volume of distribution(Vd/F)
timeFrame: 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
measure: Apparent clearance (CLz/F)
timeFrame: 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
measure: End elimination rate (λz)
timeFrame: 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
measure: Residual area percentage (AUC_%Extrap)
timeFrame: 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
measure: Average dwell time(MRT0-t)
timeFrame: 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
measure: Average dwell time(MRT0-∞)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
city: Chengdu
country: China
facility: The Third People Hospital of Chengdu
state: Sichuan
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: