CClinicalTrials.gg
CompletedNCT07447141Updated Mar 3, 2026

DBM-1152A Inhalation Solution in Chinese Healthy Subjects

A Phase 1 interventional study of DBM-1152A Inhalation Solution and Placebo in Health and Health Adult Subjects, sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Joincare Pharmaceutical Group Industry Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Dec 2023, registered Feb 2026).
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Health
  • Health Adult Subjects

Keywords

  • COPD
  • Asthma
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 44 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Joincare Pharmaceutical Group Industry Co., Ltd is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Chinese healthy male or female subjects.
  2. Age 18 to 45 years (inclusive).
  3. Body weight: Male ≥50.0kg, Female≥45.0 kg; BMI within the range of 19.0 to 26.0 kg/m\^2 (inclusive).
  4. Subjects (including their partners) are willing to use effective contraception from the screening period until 6 months after the last dose.
  5. Subjects must fully understand the study, participate voluntarily, and sign the written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Positive results in virology screening (HBsAg, anti-HCV, anti-HIV, or TP-Ab).
  3. 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.
  4. Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTc): Male ≥ 450 ms, Female ≥ 470 ms.
  5. Electrolyte or glucose abnormalities at screening: Hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia, or hyperglycemia.
  6. Current acute or chronic oral or pharyngeal diseases (e.g., oral ulcers, pharyngitis).
  7. 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.
  8. History or presence of glaucoma, functional constipation, prostatic hyperplasia, urinary tract obstruction, urinary retention, epilepsy, hyperthyroidism, paradoxical bronchospasm, diabetes, or ketoacidosis.
  9. History or presence of Short QT Syndrome or Long QT Syndrome.
  10. Lower respiratory tract infection within 6 weeks prior to screening, or clinically significant upper respiratory tract disease within 2 weeks prior to screening.
  11. Surgery within 3 months prior to screening, especially procedures affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study.
  12. 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.
  13. History of drug abuse or drug dependence within 12 months prior to screening.
  14. Positive drug screening (morphine, methamphetamine, ketamine, MDMA, or THC) prior to enrollment.
  15. 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.
  16. 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.
  17. Positive breath alcohol test (> 0 mg/100 mL) prior to enrollment.
  18. Current smoker or history of smoking.
  19. Positive nicotine test prior to enrollment.
  20. Use of any medications (including prescription, OTC, vitamins, herbal medicine, supplements, or vaccines) within 30 days prior to screening.
  21. Participation in any clinical trial of a drug or device within 3 months prior to screening.
  22. 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.
  23. Difficulty in venous blood collection or inability to tolerate venipuncture.
  24. History of needle syncope or blood syncope.
  25. Inability to tolerate inhalation administration.
  26. Strenuous exercise within 48 hours prior to screening.
  27. 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.
  28. 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.
  29. Special dietary requirements or inability to comply with the standardized diet.
  30. Poor compliance.
  31. Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    1 mg DBM-1152A

    Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label)

    Drug: DBM-1152A Inhalation Solution

  • Experimental
    2 mg DBM-1152A

    Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution.

    Drug: DBM-1152A Inhalation Solution

  • Experimental
    4 mg DBM-1152A

    Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution

    Drug: DBM-1152A Inhalation Solution

  • Experimental
    6 mg DBM-1152A

    Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution.

    Drug: DBM-1152A Inhalation Solution

  • Experimental
    9 mg DBM-1152A

    Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution.

    Drug: DBM-1152A Inhalation Solution

  • Placebo comparator
    Placebo

    Participants receive a single dose of matching placebo (blank vehicle) corresponding to the 2 mg, 4 mg, 6 mg, or 9 mg cohorts.

    Drug: Placebo

Interventions

  • DrugDBM-1152A Inhalation Solution

    Single dose via oral inhalation nebulization.

  • DrugPlacebo

    Single dose of blank vehicle via oral inhalation nebulization.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From informed consent up to Day 4 (End of study).

Secondary outcomes

  1. Peak Plasma Concentration (Cmax) of DBM-1152A

    Maximum observed plasma concentration.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  2. 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.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  3. 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.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  4. Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A

    Time to reach maximum observed plasma concentration.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  5. Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A

    Apparent terminal elimination half-life.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  6. Apparent Total Plasma Clearance (CL/F) of DBM-1152A

    Apparent total plasma clearance calculated as dose divided by AUC0-∞.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  7. Apparent Volume of Distribution (Vz/F) of DBM-1152A

    Apparent volume of distribution during the terminal phase.

    Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

  8. Cumulative Amount of DBM-1152A Excreted Unchanged in Urine (Ae) (6 mg Cohort Only)

    Cumulative amount of unchanged drug excreted in the urine.

    Time frame: Pre-dose (within 24 hours before dosing) up to 72 hours post-dose.

07

Study locations

1 site
  • Xuzhou Central Hospital
    Xuzhou, Jiangsu, China
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07447141
Lead sponsor
Joincare Pharmaceutical Group Industry Co., Ltd
Collaborators
Livzon Pharmaceutical Group Inc.
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Dec 24, 2023
Primary completion
Apr 8, 2024
Completion
Apr 8, 2024
Last update
Mar 3, 2026

Study contacts

Yanmin Wu
principal investigator · Xuzhou Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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