Chronic Obstructive Pulmonary DiseasePhase 1NCT06711991
A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease
A Phase 1 study testing TQC3927 powder for inhalation in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TQC3927 powder for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesChina
- Study dates
- 11 Feb 2025to 11 Aug 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
China Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
Aerospace Center Hospital
Beijing, Beijing Municipality, 100049
The Third People Hospital of Chengdu
Chengdu, Sichuan, 610031
Heze Municipal Hospital
Heze, Shandong, 274031
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Zibo Municipal Hospital
Zibo, Shandong, 255400
About this study
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
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
- Being tested
- TQC3927 powder for inhalation, TQC3927 powder for inhalation placebo
- 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.
TQC3927 powder for inhalationDrug
TQC3927 is a targeted inhibitor
TQC3927 powder for inhalation placeboDrug
A placebo without drug substance.
| Study group | Role | What they receive |
|---|---|---|
| TQC3927 powder for inhalation | Experimental | TQC3927 powder for inhalation is administered as a single administration for 1 day and continuous administration for 6 days. Receives: 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. Receives: Drug: TQC3927 powder for inhalation placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
The occurrence of all adverse events (AE) including abnormal laboratory test indicators.
Measured: 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) .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: After administration of Day1 and Day7，before administration of Day3 and Day5
Secondary outcomes (11)
Peak concentration (Cmax)
The Cmax is the maximum observed plasma concentration of study drug.
Measured: 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])
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Measured: 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])
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Measured: 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)
To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing.
Measured: 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)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: 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
Apparent volume of distribution(Vd/F)
Apparent volume of distribution of the TQC3927 in plasma
Measured: 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
Apparent clearance (CLz/F)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 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
End elimination rate (λz)
Derived from semi logarithmic linear regression of eliminating phase concentration points.
Measured: 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
Residual area percentage (AUC_%Extrap)
Residual area percentage of the TQC3927 in plasma.
Measured: 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
Average dwell time(MRT0-t)
The average residence time from 0:00 to the last measurable concentration time point.
Measured: 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
Average dwell time(MRT0-∞)
Average residence time from 0:00 to infinity.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start11 Feb 2025
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
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
- 48 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
- NCT06711991
- Sponsor's protocol ID
- TQC3927-I-02
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 15 Aug 2025
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06711991
- Acronym / sponsor ID
- TQC3927-I-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 2 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 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
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 |
|---|---|---|
| TQC3927 powder for inhalation | Experimental | Drug: TQC3927 powder for inhalationTQC3927 powder for inhalation is administered as a single administration for 1 day and continuous administration for 6 days. |
| TQC3927 powder for inhalation placebo | Active comparator | Drug: TQC3927 powder for inhalation placeboTQC3927 powder for inhalation placebo is administered as a single administration for 1 day and continuous administration for 6 days. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| TQC3927 powder for inhalationTQC3927 is a targeted inhibitor | Drug | TQC3927 powder for inhalation |
| TQC3927 powder for inhalation placeboA placebo without drug substance. | Drug | TQC3927 powder for inhalation placebo |
Primary outcome
Adverse events (AE)
Time frame: From the use of the investigational drug until the last study visit, up to day 16
The occurrence of all adverse events (AE) including abnormal laboratory test indicators.
Serious adverse events (SAE)
Time frame: From the use of the investigational drug until the last study visit, up to day 16
The occurrence of all serious adverse events (SAE) .
Forced expiratory volume (FEV1) trough value changed from baseline
Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5
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.
Forced vital capacity (FVC) changes compared to baseline
Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5
FVC changes compared to baseline at each lung function visit point.
The peak FEV1 value changed from baseline
Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5
After administration of Day1 and Day7, the peak FEV1 value changed from baseline.
The area under the FEV1 curve of the average change from baseline
Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5
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).
The change in chronic obstructive pulmonary disease (CAT) score from baseline
Time frame: After administration of Day1 and Day7，before administration of Day3 and Day5
The change in chronic obstructive pulmonary disease (CAT) score from baseline on the day after Day7 administration.
11 secondary outcomes
Peak concentration (Cmax)
Time frame: 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])
Time frame: 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])
Time frame: 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)
Time frame: 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)
Time frame: 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
Apparent volume of distribution(Vd/F)
Time frame: 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
Apparent clearance (CLz/F)
Time frame: 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
End elimination rate (λz)
Time frame: 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
Residual area percentage (AUC_%Extrap)
Time frame: 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
Average dwell time(MRT0-t)
Time frame: 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
Average dwell time(MRT0-∞)
Time frame: 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
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 15 Aug 2025.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQC3927 powder for inhalation in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites 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 4 inclusion and 12 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 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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: From the use of the investigational drug until the last study visit, up to day 16). 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 15 Aug 2025.