Chronic Obstructive Pulmonary DiseasePhase 1NCT05051930
A Clinical Trial of TQC3721 Suspension for Inhalation
A Phase 1 study testing TQC3721 suspension for inhalation in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TQC3721 suspension for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- 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）;
- For patients: beta agonists are currently used only "when needed";
- For patients: Never smoked or An ex-smoker for ≥6 months；
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- For patients: Intolerance to salbutamol, tiotropium, or this product or prior exposure to Ensifentrine (RPL554).
- For patients: Use of any medicine within 4 weeks prior to initiation of the study drug, including non-prescription medications and herbs, except vitamins.
- For patients: Physical examination findings that researchers consider clinically significant at the time of screening.
- For patients: A history of cardiovascular disease (including arrhythmias) or active hyperthyroidism.
- For patients: History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Weimin Li, Post Doctor, 028-85423837, llllllv2@126.com
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Efficacy of TQC3721 Suspension for Inhalation
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
- Being tested
- TQC3721 suspension for inhalation, TQC3721 suspension placebo for inhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC3721 suspension for inhalationDrug
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 placebo for inhalationDrug
Participants will receive 0mg single dose of TQC3721 suspension placebo for inhalation .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TQC3721 suspension placebo for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
The Number of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 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
Measured: 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
Measured: 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
Measured: From the enrollment of the subjects to 72 hours after the last administration
Area Under The Curve（AUC）
Area under the curve
Measured: Within 60 minutes before each administration, to 72 hours after administration
Plasma drug peak concentration（Cmax ）
Plasma drug peak concentration
Measured: Within 60 minutes before each administration, to 72 hours after administration
Time to peak（Tmax）
Time to maximum concentration following drug administration
Measured: Within 60 minutes before each administration, to 72 hours after administration
Secondary outcomes (8)
Elimination half-life time（t1/2）
Apparent terminal elimination half-life following drug administration
Measured: Within 60 minutes before each administration, to 72 hours after administration
Apparent volume of distribution（Vd）
Apparent volume of distribution
Measured: Within 60 minutes before each administration, to 72 hours after administration
Clearance（CL）
Clearance
Measured: 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
Mean Change From Baseline in Peak FEV1 (Over 3 Hours)
Measured: From before administration to 3 hours after administration
Mean Change From Baseline FEV1 to Morning Trough FEV1
Mean Change From Baseline FEV1 to Morning Trough FEV1
Measured: From the enrollment of the subjects to to 72 hours after administration
Mean Change From Baseline FEV1 to Average FEV1
Mean Change From Baseline FEV1 to Average FEV1
Measured: From the enrollment of the subjects to to 72 hours after administration
COPD Assessment Test (CAT) for patients with COPD
Mean Change From Baseline in COPD Assessment Test (CAT) Scoring at Week 4.The score range is 0 to 40 (0 to 10 is minor influence;11 to 20 is moderate; 21 to30 is severe;31 to 40 is very severe), and more than 10 indicates more symptoms.
Measured: From enrollment to 4 weeks after administration
Modified medical research council(mMRC) for patients with COPD or asthma
Mean Change From Baseline in mMRC Scoring at Week 4.The severity is measured on a five-point scale from 0 to 4, with a higher score indicating more severe respiratory distress.
Measured: From enrollment to 4 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start18 Oct 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051930
- Sponsor's protocol ID
- TQC3721-I-01
- Status last verified
- Oct 2021
- First submitted
- 17 Aug 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Efficacy of TQC3721 Suspension for Inhalation
- ClinicalTrials.gov ID
- NCT05051930
- Acronym / sponsor ID
- TQC3721-I-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQC3721 suspension for inhalation | Experimental | Drug: TQC3721 suspension for inhalationParticipants 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. |
| TQC3721 suspension placebo for inhalation | Placebo comparator | Drug: TQC3721 suspension placebo for inhalationParticipants will receive 0mg single dose of TQC3721 suspension placebo for inhalation on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC3721 suspension for inhalationParticipants 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. | Drug | TQC3721 suspension for inhalation |
| TQC3721 suspension placebo for inhalationParticipants will receive 0mg single dose of TQC3721 suspension placebo for inhalation . | Drug | TQC3721 suspension placebo for inhalation |
Primary outcome
Number of adverse events
Time frame: From the enrollment of the subjects to 72 hours after the last administration
The Number of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence of adverse events
Time frame: From the enrollment of the subjects to 72 hours after the last administration
The Incidence of adverse events as assessed by CTCAE v5.0
Number of adverse events related to the study drug
Time frame: From the enrollment of the subjects to 72 hours after the last administration
The number of adverse events associated with the study drug assessed by CTCAE V5.0
Incidence of adverse events associated with the study drug
Time frame: From the enrollment of the subjects to 72 hours after the last administration
Incidence of adverse events associated with the study drug as assessed by CTCAE V5.0
Area Under The Curve（AUC）
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Area under the curve
Plasma drug peak concentration（Cmax ）
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Plasma drug peak concentration
Time to peak（Tmax）
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Time to maximum concentration following drug administration
8 secondary outcomes
Elimination half-life time（t1/2）
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Apparent volume of distribution（Vd）
Time frame: Within 60 minutes before each administration, to 72 hours after administration
Clearance（CL）
Time frame: 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
Time frame: From before administration to 3 hours after administration
Mean Change From Baseline FEV1 to Morning Trough FEV1
Time frame: From the enrollment of the subjects to to 72 hours after administration
Mean Change From Baseline FEV1 to Average FEV1
Time frame: From the enrollment of the subjects to to 72 hours after administration
COPD Assessment Test (CAT) for patients with COPD
Time frame: From enrollment to 4 weeks after administration
Modified medical research council(mMRC) for patients with COPD or asthma
Time frame: From enrollment to 4 weeks after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQC3721 suspension for inhalation in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weimin Li, Post Doctor (028-85423837, llllllv2@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: From the enrollment of the subjects to 72 hours after the last administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.