Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT06748079
A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
A Phase 1 study testing TQC3721 inhalation powder in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- TQC3721 inhalation powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 7 Aug 2026
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40-75 years old, male or female;
- During screening, according to the Global Oceanographic Library for Discovery (GOLD)guidelines (2024), patients diagnosed with stable moderate to severe COPD should have Force Expiratory Volume in 1 second (FEV1)/ forced vital capacity (FVC)<0.7 after inhaling bronchodilators; 40% ≤ FEV1 accounts for ≤ 80% of the expected value;
- When screening, after inhaling salbutamol aerosol for 4 times, there is a certain reversibility in the airway: the absolute value of FEV1 improves by more than 100ml;
- 4.1Applicable to Part 1: Being able to adjust the current COPD treatment or for COPD patients with initial treatment, prescribed bronchodilators, including Long-acting Muscarinic Antagonists (LAMA) and/or Long-acting β2-agonist (LABA) inhaled drugs, can be discontinued during the screening period after signing the informed consent form; 4.2 Applicable to Part 2: Being able to adjust the current COPD treatment or for COPD patients with initial treatment,LAMA inhaled drugs can be used during the lead-in period after signing the informed consent form;
- 5.The subject is able to discontinue Short acting Beta agonists (SABA) for at least 6 hours and Short acting Anticholinergic Agents (SAMA) for at least 8 hours; 6.Smoking history ≥ 10 pack years (pack years: number of packs per day multiplied by smoking years); 7.There is no evidence to suggest active respiratory and/or cardiovascular diseases other than COPD in clinical practice (such as uncontrolled hypertension); 8.No other related lung diseases or history of thoracic surgery; 9.The subjects were able to undergo reproducible FEV1 lung function testing according to the ATS/ERS 2005 standard during screening; 10. Body mass index (BMI) is between 18-30kg/m2; 11.Participants must agree to use contraceptive methods (such as birth control pills, condoms, or intrauterine devices) with sexual partners of childbearing age during the clinical trial period (screening period to 30 days after the last dose); 12) The subject is able to use a dry powder inhaler correctly for inhalation. 13) I have fully understood this study and voluntarily participated. I have signed the 'Informed Consent Form'.
Who cannot join
- 1 . History or current clinical instability of heart, respiratory, endocrine, metabolic, renal, liver, gastrointestinal, skin, infection, blood system, nervous system, or neurological/psychiatric disorders/abnormalities; 2. The result of the human immunodeficiency virus (HIV) antibody test is positive; The result of hepatitis B surface antigen (HBsAg) test is positive (if HBsAg is positive, Hepatitis B virus deoxyribonucleic acid (HBV-DNA) should be checked if necessary, and if HBV-DNA<Lower Limit of Quantification (LLOQ), it does not need to be excluded); Hepatitis C virus (HCV) antibody positive and confirmed presence of HCV ribonucleic acid (RNA); Positive for Treponema pallidum antibody (TPPA); 3. Have a history of illegal drug abuse in the past; 4. Have participated in other clinical trials and received the investigational drug within 3 months prior to participating in this trial, or within 5 half lives of the investigational drug, whichever is shorter; 5. Those who have lost blood or donated more than 400 mL of blood within 2 months before the experiment; 6. Have any clear and severe history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug; 7. Drinking history (drinking 14 units of alcohol per week: 1 unit=285 ml of beer; or 25 ml of spirits; or 1 glass of wine); 8. History of malignant tumors in any organ system within the past 5 years, regardless of whether treatment has been received or not, except for local basal cell carcinoma of the skin; 9. Lower respiratory tract infection occurred within 6 weeks before screening or randomization. Upper respiratory tract infections requiring antibiotics within 6 weeks prior to screening or randomization; 10. Have a history of active tuberculosis, bronchiectasis, asthma or other non-specific lung diseases.
- 11. QTcF (corrected QT interval, Fridericia formula QT [msec]/RR [s]) interval, male>450ms, female>470ms, or history of long QT syndrome before screening or randomization; 12. Subjects with a history of drug use in the past 2 years; 13. Subjects who are unable to comply with past medication and concomitant medication restrictions; 14. If there is a history of acute exacerbation of COPD within 3 months before screening or randomization, hospitalization or additional COPD maintenance treatment is required. Over the past three years, the average number of frequent exacerbations of COPD with moderate to severe severity has been ≥ 2 per year, or resulting in hospitalization for ≥ 2 acute exacerbations per year; 15. Oral non selective beta blockers; 16. Previously treated with TQC3721 suspension. 17. Any situation that researchers believe may pose safety risks to subjects in the trial or may interfere with the conduct of this study, or where researchers believe that subjects may not be able to complete this study or may not be able to comply with the requirements of this study (due to management or other reasons).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.
- Being tested
- TQC3721 inhalation powder, Placebo for TQC3721 inhalation powder, TQC3721 inhalation powder combined with glyberlam inhalation powder or a control group
- 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 inhalation powderDrug
TQC3721 is a target inhibitor.
Placebo for TQC3721 inhalation powderDrug
Placebo without drug substance.
TQC3721 inhalation powder combined with glyberlam inhalation powder or a control groupDrug
TQC3721 is a target inhibitor
| Study group | Role | What they receive |
|---|---|---|
| TQC3721 inhalation powder | Experimental | TQC3721 inhalation powder is administered as a single dose or continuously for 7 days. Receives: Drug: TQC3721 inhalation powder |
| Placebo for TQC3721 inhalation powder | Placebo comparator | Placebo for TQC3721 inhalation powder inhalation is administered as a single dose or continuously for 7 days. Receives: Drug: Placebo for TQC3721 inhalation powder |
| TQC3721 Inhaler Powder + Glimetrexate Inhaler Powder / Control Group | Experimental | TQC3721 inhalation powder combined with glyberlam inhalation powder or a control group for 14 consecutive days of inhalation administration. Receives: Drug: TQC3721 inhalation powder combined with glyberlam inhalation powder or a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
Incidence of adverse events (AE)
Measured: 21 days
Serious Adverse Events (SAE)
Incidence of Serious Adverse Events (SAE)
Measured: 21 days
Treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 19 days
Secondary outcomes (4)
Plasma drug peak concentration
Plasma drug peak concentration after administration.
Measured: 9 days
COPD Assessment Tes (CAT) scores
CAT score after administration. The score range is 0 to 40 points (0 to 10 is minor influence; 11 to 20 are moderate; 21 to 30 are classified as severe impact; 31 to 40 is very severe).
Measured: From day 1 to day 11 or end of treatment, whichever came first
PD indices: Pulmonary function test parameters
CAT scores of COPD patients after multiple doses of TQC3721 DPI
Measured: From D-1 to End of Treatment(EOT).
Serum and sputum inflammatory cells
Changes in inflammatory cells in serum and sputum following treatment
Measured: From D-1 to D11 or End of EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 Dec 2024
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
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
- NCT06748079
- Sponsor's protocol ID
- TQC3721-D8-I-01
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2024
- Last updated
- 11 Aug 2026
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of Single/Multiple Dose Escalation of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06748079
- Acronym / sponsor ID
- TQC3721-D8-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 24 Dec 2024 (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.
This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQC3721 inhalation powder | Experimental | Drug: TQC3721 inhalation powderTQC3721 inhalation powder is administered as a single dose or continuously for 7 days. |
| Placebo for TQC3721 inhalation powder | Placebo comparator | Drug: Placebo for TQC3721 inhalation powderPlacebo for TQC3721 inhalation powder inhalation is administered as a single dose or continuously for 7 days. |
| TQC3721 Inhaler Powder + Glimetrexate Inhaler Powder / Control Group | Experimental | Drug: TQC3721 inhalation powder combined with glyberlam inhalation powder or a control groupTQC3721 inhalation powder combined with glyberlam inhalation powder or a control group for 14 consecutive days of inhalation administration. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 40-75 years old, male or female;
- During screening, according to the Global Oceanographic Library for Discovery (GOLD)guidelines (2024), patients diagnosed with stable moderate to severe COPD should have Force Expiratory Volume in 1 second (FEV1)/ forced vital capacity (FVC)<0.7 after inhaling bronchodilators; 40% ≤ FEV1 accounts for ≤ 80% of the expected value;
- When screening, after inhaling salbutamol aerosol for 4 times, there is a certain reversibility in the airway: the absolute value of FEV1 improves by more than 100ml;
- 4.1Applicable to Part 1: Being able to adjust the current COPD treatment or for COPD patients with initial treatment, prescribed bronchodilators, including Long-acting Muscarinic Antagonists (LAMA) and/or Long-acting β2-agonist (LABA) inhaled drugs, can be discontinued during the screening period after signing the informed consent form; 4.2 Applicable to Part 2: Being able to adjust the current COPD treatment or for COPD patients with initial treatment,LAMA inhaled drugs can be used during the lead-in period after signing the informed consent form;
- 5.The subject is able to discontinue Short acting Beta agonists (SABA) for at least 6 hours and Short acting Anticholinergic Agents (SAMA) for at least 8 hours; 6.Smoking history ≥ 10 pack years (pack years: number of packs per day multiplied by smoking years); 7.There is no evidence to suggest active respiratory and/or cardiovascular diseases other than COPD in clinical practice (such as uncontrolled hypertension); 8.No other related lung diseases or history of thoracic surgery; 9.The subjects were able to undergo reproducible FEV1 lung function testing according to the ATS/ERS 2005 standard during screening; 10. Body mass index (BMI) is between 18-30kg/m2; 11.Participants must agree to use contraceptive methods (such as birth control pills, condoms, or intrauterine devices) with sexual partners of childbearing age during the clinical trial period (screening period to 30 days after the last dose); 12) The subject is able to use a dry powder inhaler correctly for inhalation. 13) I have fully understood this study and voluntarily participated. I have signed the 'Informed Consent Form'.
Key exclusion criteria (2 listed)
- 1 . History or current clinical instability of heart, respiratory, endocrine, metabolic, renal, liver, gastrointestinal, skin, infection, blood system, nervous system, or neurological/psychiatric disorders/abnormalities; 2. The result of the human immunodeficiency virus (HIV) antibody test is positive; The result of hepatitis B surface antigen (HBsAg) test is positive (if HBsAg is positive, Hepatitis B virus deoxyribonucleic acid (HBV-DNA) should be checked if necessary, and if HBV-DNA<Lower Limit of Quantification (LLOQ), it does not need to be excluded); Hepatitis C virus (HCV) antibody positive and confirmed presence of HCV ribonucleic acid (RNA); Positive for Treponema pallidum antibody (TPPA); 3. Have a history of illegal drug abuse in the past; 4. Have participated in other clinical trials and received the investigational drug within 3 months prior to participating in this trial, or within 5 half lives of the investigational drug, whichever is shorter; 5. Those who have lost blood or donated more than 400 mL of blood within 2 months before the experiment; 6. Have any clear and severe history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug; 7. Drinking history (drinking 14 units of alcohol per week: 1 unit=285 ml of beer; or 25 ml of spirits; or 1 glass of wine); 8. History of malignant tumors in any organ system within the past 5 years, regardless of whether treatment has been received or not, except for local basal cell carcinoma of the skin; 9. Lower respiratory tract infection occurred within 6 weeks before screening or randomization. Upper respiratory tract infections requiring antibiotics within 6 weeks prior to screening or randomization; 10. Have a history of active tuberculosis, bronchiectasis, asthma or other non-specific lung diseases.
- 11. QTcF (corrected QT interval, Fridericia formula QT [msec]/RR [s]) interval, male>450ms, female>470ms, or history of long QT syndrome before screening or randomization; 12. Subjects with a history of drug use in the past 2 years; 13. Subjects who are unable to comply with past medication and concomitant medication restrictions; 14. If there is a history of acute exacerbation of COPD within 3 months before screening or randomization, hospitalization or additional COPD maintenance treatment is required. Over the past three years, the average number of frequent exacerbations of COPD with moderate to severe severity has been ≥ 2 per year, or resulting in hospitalization for ≥ 2 acute exacerbations per year; 15. Oral non selective beta blockers; 16. Previously treated with TQC3721 suspension. 17. Any situation that researchers believe may pose safety risks to subjects in the trial or may interfere with the conduct of this study, or where researchers believe that subjects may not be able to complete this study or may not be able to comply with the requirements of this study (due to management or other reasons).
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 inhalation powderTQC3721 is a target inhibitor. | Drug | TQC3721 inhalation powder |
| Placebo for TQC3721 inhalation powderPlacebo without drug substance. | Drug | Placebo for TQC3721 inhalation powder |
| TQC3721 inhalation powder combined with glyberlam inhalation powder or a control groupTQC3721 is a target inhibitor | Drug | TQC3721 Inhaler Powder + Glimetrexate Inhaler Powder / Control Group |
Primary outcome
Adverse events (AE)
Time frame: 21 days
Incidence of adverse events (AE)
Serious Adverse Events (SAE)
Time frame: 21 days
Incidence of Serious Adverse Events (SAE)
Treatment-emergent adverse events (TEAEs)
Time frame: 19 days
Incidence of treatment-emergent adverse events (TEAEs)
4 secondary outcomes
Plasma drug peak concentration
Time frame: 9 days
COPD Assessment Tes (CAT) scores
Time frame: From day 1 to day 11 or end of treatment, whichever came first
PD indices: Pulmonary function test parameters
Time frame: From D-1 to End of Treatment(EOT).
Serum and sputum inflammatory cells
Time frame: From D-1 to D11 or End of EOT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 inhalation powder in people with Chronic Obstructive Pulmonary Disease (COPD), 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 11 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) (time frame: 21 days). The study lists 3 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 11 Aug 2026.