HealthPhase 1NCT07447141
DBM-1152A Inhalation Solution in Chinese Healthy Subjects
A Phase 1 study testing DBM-1152A Inhalation Solution in people with Health and Health Adult Subjects, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial summary
This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Health Adult Subjects
- What is being tested?
- DBM-1152A Inhalation Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2023to 8 Apr 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
- Chinese healthy male or female subjects.
- Age 18 to 45 years (inclusive).
- Body weight: Male ≥50.0kg, Female≥45.0 kg; BMI within the range of 19.0 to 26.0 kg/m^2 (inclusive).
- Subjects (including their partners) are willing to use effective contraception from the screening period until 6 months after the last dose.
- Subjects must fully understand the study, participate voluntarily, and sign the written informed consent.
Who cannot join
- Clinically significant abnormalities in physical examination, chest X-ray, hematology, urinalysis, blood biochemistry, coagulation function, thyroid function, or ophthalmic examination during screening; or FEV1/FVC < 80% in pulmonary function tests.
- Positive results in virology screening (HBsAg, anti-HCV, anti-HIV, or TP-Ab).
- Abnormal vital signs at screening: Sitting systolic blood pressure < 90 mmHg or ≥ 140 mmHg, diastolic blood pressure < 55 mmHg or ≥ 90 mmHg; Pulse < 50 bpm or > 90 bpm; Body temperature < 35.9°C or > 37.6°C; Respiratory rate < 12 breaths/min or > 20 breaths/min.
- Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTc): Male ≥ 450 ms, Female ≥ 470 ms.
- Electrolyte or glucose abnormalities at screening: Hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia, or hyperglycemia.
- Current acute or chronic oral or pharyngeal diseases (e.g., oral ulcers, pharyngitis).
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- History or presence of chronic or severe diseases in the endocrine, urinary, digestive, hematological, respiratory, cardiovascular, neuropsychiatric, or immune systems, or any other physiological condition that may interfere with the study results.
- History or presence of glaucoma, functional constipation, prostatic hyperplasia, urinary tract obstruction, urinary retention, epilepsy, hyperthyroidism, paradoxical bronchospasm, diabetes, or ketoacidosis.
- History or presence of Short QT Syndrome or Long QT Syndrome.
- Lower respiratory tract infection within 6 weeks prior to screening, or clinically significant upper respiratory tract disease within 2 weeks prior to screening.
- Surgery within 3 months prior to screening, especially procedures affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study.
- Suspected allergy to DBM-1152A or its excipients; history of hypersensitivity to other anticholinergic drugs or β2-agonists; or history of significant food or drug allergies.
- History of drug abuse or drug dependence within 12 months prior to screening.
- Positive drug screening (morphine, methamphetamine, ketamine, MDMA, or THC) prior to enrollment.
- Excessive consumption of tea, coffee, or caffeinated beverages (≥8 cups/day, 250mL/cup) within the past 6 months; or consumption of caffeine-rich or grapefruit-rich food/beverages within 48 hours prior to screening.
- History of alcohol abuse within the past 12 months (Male ≥ 28 units/week, Female ≥ 21 units/week); or regular drinking (≥14 units/week) within 6 months prior to screening; or inability to abstain from alcohol during the study.
- Positive breath alcohol test (> 0 mg/100 mL) prior to enrollment.
- Current smoker or history of smoking.
- Positive nicotine test prior to enrollment.
- Use of any medications (including prescription, OTC, vitamins, herbal medicine, supplements, or vaccines) within 30 days prior to screening.
- Participation in any clinical trial of a drug or device within 3 months prior to screening.
- Blood donation or significant blood loss (> 400 mL) within 3 months prior to screening; or planned blood donation during or within 3 months after the study.
- Difficulty in venous blood collection or inability to tolerate venipuncture.
- History of needle syncope or blood syncope.
- Inability to tolerate inhalation administration.
- Strenuous exercise within 48 hours prior to screening.
- Pregnant or lactating women, or women planning pregnancy; use of long-acting estrogen/progestogen injections or implants within 6 months prior to screening; or positive pregnancy test.
- Male subjects (or their partners) or female subjects planning pregnancy, sperm donation, or egg donation within 6 months after the study, or unwilling to use contraception.
- Special dietary requirements or inability to comply with the standardized diet.
- Poor compliance.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single-center, Placebo-controlled, Dose-escalation Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of DBM-1152A Inhalation Solution in Chinese Healthy Subjects
This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects.
- Conditions
- Health, Health Adult Subjects
- Being tested
- DBM-1152A Inhalation Solution, Placebo
- Keywords
- COPD, Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBM-1152A Inhalation SolutionDrug
Single dose via oral inhalation nebulization.
PlaceboDrug
Single dose of blank vehicle via oral inhalation nebulization.
| Study group | Role | What they receive |
|---|---|---|
| 1 mg DBM-1152A | Experimental | Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label) Receives: Drug: DBM-1152A Inhalation Solution |
| 2 mg DBM-1152A | Experimental | Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution. Receives: Drug: DBM-1152A Inhalation Solution |
| 4 mg DBM-1152A | Experimental | Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution Receives: Drug: DBM-1152A Inhalation Solution |
| 6 mg DBM-1152A | Experimental | Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution. Receives: Drug: DBM-1152A Inhalation Solution |
| 9 mg DBM-1152A | Experimental | Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution. Receives: Drug: DBM-1152A Inhalation Solution |
| Placebo | Placebo comparator | Participants receive a single dose of matching placebo (blank vehicle) corresponding to the 2 mg, 4 mg, 6 mg, or 9 mg cohorts. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Safety and tolerability are evaluated through adverse events (AEs), vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), 12-lead ECG, Holter monitoring, and pupil examination.
Measured: From informed consent up to Day 4 (End of study).
Secondary outcomes (8)
Peak Plasma Concentration (Cmax) of DBM-1152A
Maximum observed plasma concentration.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of DBM-1152A
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of DBM-1152A
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A
Time to reach maximum observed plasma concentration.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A
Apparent terminal elimination half-life.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Total Plasma Clearance (CL/F) of DBM-1152A
Apparent total plasma clearance calculated as dose divided by AUC0-∞.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Volume of Distribution (Vz/F) of DBM-1152A
Apparent volume of distribution during the terminal phase.
Measured: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Cumulative Amount of DBM-1152A Excreted Unchanged in Urine (Ae) (6 mg Cohort Only)
Cumulative amount of unchanged drug excreted in the urine.
Measured: Pre-dose (within 24 hours before dosing) up to 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Dec 2023
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Livzon Pharmaceutical Group Inc.
- Responsible party
- Sponsor
- Investigators
- Yanmin Wu, Principal investigator, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447141
- Sponsor's protocol ID
- CTP-23041I-A
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the sponsor organization. Data are not being made publicly available due to participant privacy and confidentiality considerations and because there is no established process for external data sharing for this study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-center, Placebo-controlled, Dose-escalation Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of DBM-1152A Inhalation Solution in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT07447141
- Acronym / sponsor ID
- CTP-23041I-A
- Conditions
- Health, Health Adult Subjects
- Keywords
- COPD, Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Livzon Pharmaceutical Group Inc.
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 3 Mar 2026 (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 Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 mg DBM-1152A | Experimental | Drug: DBM-1152A Inhalation SolutionParticipants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label) |
| 2 mg DBM-1152A | Experimental | Drug: DBM-1152A Inhalation SolutionParticipants receive a single dose of 2 mg DBM-1152A Inhalation Solution. |
| 4 mg DBM-1152A | Experimental | Drug: DBM-1152A Inhalation SolutionParticipants receive a single dose of 4 mg DBM-1152A Inhalation Solution |
| 6 mg DBM-1152A | Experimental | Drug: DBM-1152A Inhalation SolutionParticipants receive a single dose of 6 mg DBM-1152A Inhalation Solution. |
| 9 mg DBM-1152A | Experimental | Drug: DBM-1152A Inhalation SolutionParticipants receive a single dose of 9 mg DBM-1152A Inhalation Solution. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive a single dose of matching placebo (blank vehicle) corresponding to the 2 mg, 4 mg, 6 mg, or 9 mg cohorts. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese healthy male or female subjects.
- Age 18 to 45 years (inclusive).
- Body weight: Male ≥50.0kg, Female≥45.0 kg; BMI within the range of 19.0 to 26.0 kg/m^2 (inclusive).
- Subjects (including their partners) are willing to use effective contraception from the screening period until 6 months after the last dose.
- Subjects must fully understand the study, participate voluntarily, and sign the written informed consent.
Key exclusion criteria (31 listed)
- Clinically significant abnormalities in physical examination, chest X-ray, hematology, urinalysis, blood biochemistry, coagulation function, thyroid function, or ophthalmic examination during screening; or FEV1/FVC < 80% in pulmonary function tests.
- Positive results in virology screening (HBsAg, anti-HCV, anti-HIV, or TP-Ab).
- Abnormal vital signs at screening: Sitting systolic blood pressure < 90 mmHg or ≥ 140 mmHg, diastolic blood pressure < 55 mmHg or ≥ 90 mmHg; Pulse < 50 bpm or > 90 bpm; Body temperature < 35.9°C or > 37.6°C; Respiratory rate < 12 breaths/min or > 20 breaths/min.
- Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTc): Male ≥ 450 ms, Female ≥ 470 ms.
- Electrolyte or glucose abnormalities at screening: Hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia, or hyperglycemia.
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 |
|---|---|---|
| DBM-1152A Inhalation SolutionSingle dose via oral inhalation nebulization. | Drug | 1 mg DBM-1152A, 2 mg DBM-1152A, 4 mg DBM-1152A, 6 mg DBM-1152A, 9 mg DBM-1152A |
| PlaceboSingle dose of blank vehicle via oral inhalation nebulization. | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Time frame: From informed consent up to Day 4 (End of study).
Safety and tolerability are evaluated through adverse events (AEs), vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), 12-lead ECG, Holter monitoring, and pupil examination.
8 secondary outcomes
Peak Plasma Concentration (Cmax) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Total Plasma Clearance (CL/F) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Volume of Distribution (Vz/F) of DBM-1152A
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Cumulative Amount of DBM-1152A Excreted Unchanged in Urine (Ae) (6 mg Cohort Only)
Time frame: Pre-dose (within 24 hours before dosing) up to 72 hours post-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 3 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the sponsor organization. Data are not being made publicly available due to participant privacy and confidentiality considerations and because there is no established process for external data sharing for this study.
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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.
Yanmin Wu principal investigator
Xuzhou Central Hospital
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 DBM-1152A Inhalation Solution in people with Health and Health Adult Subjects, run by Joincare Pharmaceutical Group Industry 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 31 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 3 Mar 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?
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability (time frame: From informed consent up to Day 4 (End of study).). 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 3 Mar 2026.