A Clinical Trial of TQC3721 Suspension for Inhalation

NCT05051930 | Unknown Phase 1

• 1 other identifier: TQC3721-I-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3721 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy TQC3721 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease（COPD）and asthma.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (7)

• Number of adverse events

  The Number of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  From the enrollment of the subjects to 72 hours after the last administration

• Incidence of adverse events

  The Incidence of adverse events as assessed by CTCAE v5.0

  From the enrollment of the subjects to 72 hours after the last administration

• Number of adverse events related to the study drug

  The number of adverse events associated with the study drug assessed by CTCAE V5.0

  From the enrollment of the subjects to 72 hours after the last administration

• Incidence of adverse events associated with the study drug

  Incidence of adverse events associated with the study drug as assessed by CTCAE V5.0

  From the enrollment of the subjects to 72 hours after the last administration

• Area Under The Curve（AUC）

  Area under the curve

  Within 60 minutes before each administration, to 72 hours after administration

• Plasma drug peak concentration（Cmax ）

  Plasma drug peak concentration

  Within 60 minutes before each administration, to 72 hours after administration

• Time to peak（Tmax）

  Time to maximum concentration following drug administration

  Within 60 minutes before each administration, to 72 hours after administration

Secondary Outcomes (8)

• Elimination half-life time（t1/2）

  Within 60 minutes before each administration, to 72 hours after administration

• Apparent volume of distribution（Vd）

  Within 60 minutes before each administration, to 72 hours after administration

• Clearance（CL）

  Within 60 minutes before each administration, to 72 hours after administration

• Forced Expiratory Volume in the first second (FEV1) for patients with Chronic Obstructive Pulmonary Disease（COPD） or asthma

  From before administration to 3 hours after administration

• Mean Change From Baseline FEV1 to Morning Trough FEV1

  From the enrollment of the subjects to to 72 hours after administration

Study Arms (2)

TQC3721 suspension for inhalation

EXPERIMENTAL

Participants will receive 0.2 mg/1.0 mg/3.0 mg/6.0 mg/12.0 mg/24.0 mg single dose of TQC3721 suspension for inhalation on Day 1.

Drug: TQC3721 suspension for inhalation

TQC3721 suspension placebo for inhalation

PLACEBO COMPARATOR

Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation on Day 1.

Drug: TQC3721 suspension placebo for inhalation

Interventions

TQC3721 suspension for inhalation DRUG

Participants will receive 0.2 mg/1.0 mg/3.0 mg/6.0 mg/12.0 mg/24.0 mg single dose of TQC3721 suspension for inhalation.

TQC3721 suspension for inhalation

TQC3721 suspension placebo for inhalation DRUG

Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation .

TQC3721 suspension placebo for inhalation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the test;
• Able to complete the study according to the requirements of protocol;
• Aged between 18 and 65 years old, both men and women;
• For healthy subjects: Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value); For patients: BMI is 18-28 kg/m2 (including the critical value), and body weight is ≥45kg.
• For healthy subjects: normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
• For healthy subjects: FEV1 and forced vital capacity(FVC) are at least 90% of the predicted values;
• Subjects (including male subjects) have no pregnancy plan and have voluntarily taken effective contraceptive measures for at least 1 month after being screened to the last use of the study drug;
• For patients: Vital signs range: systolic blood pressure 90 to 140mmHg, diastolic blood pressure 50 to 90 mmHg, heart rate 50 to 90 bpm;
• For patients: 12-lead electrocardiogram with QT interval corrected ≤450 msec (males) or ≤470 msec (females), QRS interval ≤120 msec, PR interval ≤200 msec and no morphologic and other clinical significant abnormalities (such as left band branch block, atrioventricular node dysfunction, ischemic ST segment abnormalities);
• For patients: Ability to perform acceptable and reproducible spirometry;
• For patients: According to the diagnostic criteria of 2018 Practical Edition of Guidelines for the Diagnosis and Treatment of COPD, the patient was diagnosed with COPD for at least 1 year;Post-bronchodilator spirometry at screening must demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥40 % to ≤80% of predicted normal;
• For patients: mMRC Scoring at screening ≥2;
• For patients: Clinically stable COPD in the previous 4 weeks;
• For patients: Capable of withdrawing long acting bronchodilators until the end of the treatment period, and short acting bronchodilators for 8 hours prior to administration of study medication;
• For patients: Current and former smokers with a smoking history of ≥10 pack years（smoking at least 20 cigarettes a day for 10 years or at least 10 cigarettes a day for 20 years）;

You may not qualify if:

• Preexisting or existing the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, immune system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator assesses that may affect drug metabolism or safety.
• For healthy subjects: Have a history of fainting needles, fainting blood.
• For healthy subjects: Known allergy to the study drug and their metabolites or any of the excipients of the formulation.
• For healthy subjects: Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
• A history of alcohol abuse in the past 6 months (14 units of alcohol consumed per week: 1 unit =360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine).
• For healthy subjects: Donated blood or had substantial loss of blood (more than 400 mL) within 2 months before the test.
• For healthy subjects: Had taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug.
• Participated in other clinical trials within 3 months prior to this study.
• Positive for hepatitis (including hepatitis B and C), human immunodeficiency virus（HIV） or syphilis at screening.
• Women who are pregnant or breast-feeding.
• Positive test for alcohol.
• For healthy subjects: Blood collection is difficult or cannot tolerate venipuncture blood collection.
• For healthy subjects: The subject is unable or can not comply with ward management regulations.
• For healthy subjects: The subject is unable to complete the study due to personal reasons.
• For healthy subjects: Any circumstances that the investigator considers to pose a safety risk to the subject during the study or may interfere with the conduct of the study.

Sponsors & Collaborators

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

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

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

Central Study Contacts

Weimin Li, Post Doctor

CONTACT

028-85423837; llllllv2@126.com

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: August 17, 2021
• First Posted: September 21, 2021
• Study Start: October 18, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

CN (1)