Chronic Obstructive Pulmonary DiseasePhase 1NCT06408285
A Study of TQC3927 Powder for Inhalation in Healthy Adult Subjects
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 1 site in China.
Trial summary
This is a dose escalation trial. The dosing regimen involves a single-dose study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in healthy adults subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2024to 19 Aug 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content;
- Healthy subjects aged between 18 and 45 years (inclusive), both male and female;
- The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19~28 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
- Participated in any clinical trial within 3 months prior to the screening period;
- Past medical history or current cardiac, breath，endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
- Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc;
- People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period；
- Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases；
- Any history of drug allergies, Individuals with a specific history of allergies or allergies；
Show all 15Show fewer
- Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 3 months Before first administration, or those who cannot stop using any tobacco-based products during the trial；
- Regular alcohol consumption within the first 6 months of screening (women drink more than 14 standard units per week and men drink more than 21 standard units per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening, or those who cannot refrain from alcohol during the trial, or those who tested positive for alcohol breath；
- History of drug or narcotics abuse or a positive result of urine drug test at screening；
- People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, chest radiograph and abdominal ultrasound during screening period；
- Those who have special dietary requirements and cannot follow a unified diet；
- Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP)；
- Pregnant or lactating women or those with positive blood pregnancy test results during the screening period；
- Subjects who are still unable to use TQC3927 inhalation powder correctly after training；
- Any situation in which the investigator believes that this poses a safety risk to the subject in the trial or may interfere with the conduct of the study, or that the investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
China Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: A Phase I Clinical Study on the Safety, Tolerance and Pharmacokinetic Characteristics of Single Dose Escalation of TQC3927 Powder for Inhalation in Healthy Adult Subjects
This is a dose escalation trial. The dosing regimen involves a single-dose study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in healthy adults subjects.
- 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
TQC3927 powder for inhalation placebo contains no active substance.
| Study group | Role | What they receive |
|---|---|---|
| TQC3927 powder for inhalation | Experimental | TQC3927 powder for inhalation is administered as a single dose Receives: Drug: TQC3927 powder for inhalation |
| TQC3927 powder for inhalation placebo | Placebo comparator | TQC3927 powder for inhalation placebo is administered as a single dose 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).
Measured: From the use of the investigational drug until the last study visit, up to Day 9.
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 9.
Abnormal security check
The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.
Measured: From the use of the investigational drug until the last study visit, up to Day 9.
Pharmacokinetics:Peak concentration (Cmax)
The Cmax is the maximum observed plasma concentration of study drug.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Apparent volume of distribution(Vd/F)
Apparent volume of distribution of the TQC3927 in plasma.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
End elimination rate (λz)
Derived from semi logarithmic linear regression of eliminating phase concentration points.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Residual area percentage of the TQC3927 (AUC_%Extrap)
Residual area percentage of the TQC3927 in plasma
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
Mean residence time from zero to last measurable concentration (MRT0-t)
The average residence time from 0:00 to the last measurable concentration time point.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Mean residence time from zero to infinity (MRT0-∞)
Average residence time from 0:00 to infinity.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine and feces (Aecum)
Accumulated excretion of drugs in urine and feces from zero to time t.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine (Aeu,cum)
Accumulated excretion of drugs in urine from zero to time t.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in feces(Aef,cum)
Accumulated excretion of drugs in feces from zero to time t.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Renal clearance (CLr)
The ability of the kidneys to clear certain substances from plasma within 1 minute.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Total drug excretion ratio in urine and feces (Fe%)
The total excretion ratio of drugs in urine and feces from zero to time t.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug excretion ratio in urine (Fe%u)
The proportion of drug excretion in urine from zero to time t.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug excretion ratio in feces (Fe%f)
The proportion of drug excretion in feces from zero to time t.
Measured: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 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 posted10 May 2024
- Study start22 May 2024
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
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
- 60 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
- NCT06408285
- Sponsor's protocol ID
- TQC3927-I-01
- Status last verified
- Jan 2024
- First submitted
- 29 Apr 2024
- Last updated
- 29 Oct 2024
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety, Tolerance and Pharmacokinetic Characteristics of Single Dose Escalation of TQC3927 Powder for Inhalation in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06408285
- Acronym / sponsor ID
- TQC3927-I-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 10 May 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 dose escalation trial. The dosing regimen involves a single-dose study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in healthy adults subjects.
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 dose |
| TQC3927 powder for inhalation placebo | Placebo comparator | Drug: TQC3927 powder for inhalation placeboTQC3927 powder for inhalation placebo is administered as a single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects voluntarily joined the study, sign informed consent form before the study and fully understand the study content;
- Healthy subjects aged between 18 and 45 years (inclusive), both male and female;
- The male subject should weigh at least 50kg, the female subject should weigh at least 45kg. And body mass index (BMI) within 19~28 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 (15 listed)
- Participated in any clinical trial within 3 months prior to the screening period;
- Past medical history or current cardiac, breath，endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
- Individuals with a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, etc;
- People who have received or are planning to receive inactive or active vaccines during the 30 days prior to the screening period and the entire study period；
- Current history of active tuberculosis, bronchiectasis or other non-specific lung diseases；
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 placeboTQC3927 powder for inhalation placebo contains no active 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 9.
The occurrence of all adverse events (AE).
Serious adverse events (SAE)
Time frame: From the use of the investigational drug until the last study visit, up to Day 9.
The occurrence of all serious adverse events (SAE).
Abnormal security check
Time frame: From the use of the investigational drug until the last study visit, up to Day 9.
The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.
Pharmacokinetics:Peak concentration (Cmax)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
The Cmax is the maximum observed plasma concentration of study drug.
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
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.
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing
Half-life (t1/2)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Apparent volume of distribution(Vd/F)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Apparent volume of distribution of the TQC3927 in plasma.
Apparent clearance (CLz/F)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
End elimination rate (λz)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Derived from semi logarithmic linear regression of eliminating phase concentration points.
Residual area percentage of the TQC3927 (AUC_%Extrap)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
Residual area percentage of the TQC3927 in plasma
Mean residence time from zero to last measurable concentration (MRT0-t)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
The average residence time from 0:00 to the last measurable concentration time point.
Mean residence time from zero to infinity (MRT0-∞)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Average residence time from 0:00 to infinity.
Accumulated excretion of drugs in urine and feces (Aecum)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine and feces from zero to time t.
Accumulated excretion of drugs in urine (Aeu,cum)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine from zero to time t.
Accumulated excretion of drugs in feces(Aef,cum)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in feces from zero to time t.
Renal clearance (CLr)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
The ability of the kidneys to clear certain substances from plasma within 1 minute.
Total drug excretion ratio in urine and feces (Fe%)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
The total excretion ratio of drugs in urine and feces from zero to time t.
Drug excretion ratio in urine (Fe%u)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
The proportion of drug excretion in urine from zero to time t.
Drug excretion ratio in feces (Fe%f)
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
The proportion of drug excretion in feces from zero to time t.
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 29 Oct 2024.
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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 TQC3927 powder 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 4 inclusion and 15 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 29 Oct 2024. 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: From the use of the investigational drug until the last study visit, up to Day 9.). The study lists 21 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 29 Oct 2024.