DBM-1152A Inhalation Solution in Healthy Volunteers

February 23, 2026 updated by: Joincare Pharmaceutical Group Industry Co., Ltd

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of DBM-1152A Inhalation Solution in Healthy Chinese Subjects

This is a single-center, randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple-dose DBM-1152A inhalation solution in healthy Chinese adults. Participants will receive once-daily nebulized inhalation dosing for 7 consecutive days. Three dose levels are planned (1 mg, 2 mg, and 4 mg), with allocation to DBM-1152A or placebo within each cohort in a 4:1 ratio. Safety assessments include treatment-emergent adverse events (TEAEs), clinical laboratory tests, vital signs, physical examinations, 12-lead ECGs, ophthalmic and pupil examinations, and Holter monitoring for exploratory concentration-QTc evaluation.

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.

Detailed Description

This study uses a single-center, randomized, double-blind, placebo-controlled, multiple-dose design in healthy Chinese adults. Three dose cohorts are planned: 1 mg, 2 mg, and 4 mg DBM-1152A inhalation solution. In each cohort, approximately 10 participants will be randomized in a 4:1 ratio to receive DBM-1152A or matching placebo. DBM-1152A and placebo will be administered by nebulized inhalation once daily for 7 consecutive days. Dose escalation to the 4 mg cohort will proceed after safety review of the 2 mg cohort following completion of dosing and post-dose safety observation.

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.
20

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. Healthy male or female subjects.
  2. Aged 18 to 45 years (inclusive) at screening.
  3. Body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI): 19.0 - 28.0 kg/m² (inclusive).
  4. Capable of understanding and providing written informed consent.
  5. Able and willing to adhere to the study protocol.

Exclusion Criteria:

  1. Clinically significant abnormalities in screening assessments (physical exam, vital signs, labs, chest X-ray, ophthalmology).
  2. Pulmonary function: FEV1/FVC < 80% at screening.
  3. Positive serology for HBsAg, HCV, HIV, or TP-Ab.
  4. Clinically significant 12-lead ECG abnormalities or QTcF > 450 ms (male) / > 470 ms (female).
  5. Acute or chronic oral/pharyngeal disease.
  6. History or presence of significant chronic diseases of any major organ system.
  7. History of specific diseases (glaucoma, constipation, BPH, urinary obstruction, epilepsy, hyperthyroidism, etc.).
  8. History of short or long QT syndrome.
  9. Respiratory infection within 6 weeks (lower) or 2 weeks (upper) prior to screening.
  10. Major surgery within 3 months prior to screening or planned during study.
  11. Hypersensitivity to study drug components or related drugs.
  12. History or evidence of drug abuse or positive drug screen.
  13. Excessive daily intake of tea, coffee, or caffeine (>8 cups) within 3 months prior to screening.
  14. Inability to refrain from certain foods/beverages containing caffeine/xanthine/glucose.
  15. Excessive alcohol consumption or positive alcohol screen.
  16. Smoking ≥5 cigarettes per day within 3 months prior to screening or positive nicotine test.
  17. Use of any drugs (including herbs/vitamins) within 30 days prior to screening.
  18. Participation in another clinical trial within 3 months prior to screening.
  19. Blood donation/loss (>400 mL) within 3 months prior to screening or planned during/after study.
  20. Difficulty with venipuncture or intolerance to intravenous access.
  21. History of needle or blood phobia.
  22. Intolerance to inhaled administration.
  23. Pregnancy, lactation, or positive pregnancy test.
  24. Unwillingness to use effective contraception during and for 6 months after the study.
  25. Special dietary requirements or inability to comply with standardized diet.
  26. Poor compliance as judged by the investigator.
  27. Any other condition considered unsuitable for participation by the investigator.

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: Arm 1 (Low Dose)
DBM-1152A 1mg (1 vial of 1mg/3ml), Inhalation, QD for 7 days.
Drug: DBM-1152A
multiple-dose via oral inhalation nebulization
Experimental: Arm 2 (Medium Dose)
DBM-1152A 2mg (1 vial of 2mg/3ml), Inhalation, QD for 7 days.
Drug: DBM-1152A
multiple-dose via oral inhalation nebulization
Placebo Comparator: Placebo
Matching placebo (solvent) administered by nebulized inhalation once daily (QD) for 7 days.
Drug: Placebo
multiple-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
Overall Safety and Tolerability Profile
Time Frame: From first dose up to 7 days after last dose (Day 14).
Comprehensive safety assessment as evaluated by the incidence, severity, and relationship to study drug of all treatment-emergent adverse events (TEAEs), clinically significant changes in vital signs (blood pressure, heart rate, respiratory rate, body temperature), clinically significant abnormalities in laboratory tests (hematology, biochemistry, urinalysis, coagulation), and clinically meaningful findings from 12-lead electrocardiograms (ECGs) and ambulatory Holter monitoring
From first dose up to 7 days after last dose (Day 14).

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) on Day 1
Time Frame: Day 1: pre-dose through 24 hours post-dose.
Maximum observed plasma concentration following dosing on Day 1.
Day 1: pre-dose through 24 hours post-dose.
Time to Peak Plasma Concentration (Tmax) on Day 1
Time Frame: Day 1: pre-dose through 24 hours post-dose.
Time to reach maximum observed plasma concentration on Day 1.
Day 1: pre-dose through 24 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) on Day 1
Time Frame: Day 1: pre-dose through 24 hours post-dose.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration on Day 1.
Day 1: pre-dose through 24 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) on Day 1
Time Frame: Day 1: pre-dose through 24 hours post-dose.
Area under the plasma concentration-time curve from time 0 to 24 hours on Day 1.
Day 1: pre-dose through 24 hours post-dose.
Peak Plasma Concentration at Steady State (Cmax,ss) on Day 7
Time Frame: Day 7: pre-dose through 120 hours after the last dose.
Maximum observed plasma concentration at steady state on Day 7.
Day 7: pre-dose through 120 hours after the last dose.
Time to Peak Plasma Concentration at Steady State (Tmax,ss) on Day 7
Time Frame: Day 7: pre-dose through 120 hours after the last dose.
Time to reach maximum observed plasma concentration at steady state on Day 7.
Day 7: pre-dose through 120 hours after the last dose.
Trough Plasma Concentration at Steady State (Cmin,ss) on Day 7
Time Frame: Day 7: pre-dose through 120 hours after the last dose.
Minimum observed plasma concentration at steady state on Day 7.
Day 7: pre-dose through 120 hours after the last 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.

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.
August 18, 2024

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.
October 18, 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.
October 18, 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 2, 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 23, 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.
February 27, 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.
February 27, 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 23, 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-B

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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