DBM-1152A Inhalation Solution in Chinese Healthy Subjects

February 27, 2026 updated by: Joincare Pharmaceutical Group Industry Co., Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Xuzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Single dose via oral inhalation nebulization.
Experimental: 2 mg DBM-1152A
Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution.
Drug: DBM-1152A Inhalation Solution
Single dose via oral inhalation nebulization.
Experimental: 4 mg DBM-1152A
Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution
Drug: DBM-1152A Inhalation Solution
Single dose via oral inhalation nebulization.
Experimental: 6 mg DBM-1152A
Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution.
Drug: DBM-1152A Inhalation Solution
Single dose via oral inhalation nebulization.
Experimental: 9 mg DBM-1152A
Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution.
Drug: DBM-1152A Inhalation Solution
Single dose via oral inhalation nebulization.
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
Single dose of blank vehicle via oral inhalation nebulization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From informed consent up to Day 4 (End of study).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax) of DBM-1152A
Time Frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Maximum observed plasma concentration.
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 versus time curve from time 0 to the time of the last quantifiable concentration.
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.
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity.
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.
Time to reach maximum observed plasma concentration.
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 terminal elimination half-life.
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 total plasma clearance calculated as dose divided by AUC0-∞.
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.
Apparent volume of distribution during the terminal phase.
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.
Cumulative amount of unchanged drug excreted in the urine.
Pre-dose (within 24 hours before dosing) up to 72 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joincare Pharmaceutical Group Industry Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Livzon Pharmaceutical Group Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanmin Wu, Xuzhou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP-23041I-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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