HealthyPhase 1NCT07439419
DBM-1152A Inhalation Solution in Healthy Volunteers
A Phase 1 study testing DBM-1152A in people with Healthy, run by Joincare Pharmaceutical Group Industry Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DBM-1152A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2024to 18 Oct 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
- Healthy male or female subjects.
- Aged 18 to 45 years (inclusive) at screening.
- Body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI): 19.0 - 28.0 kg/m² (inclusive).
- Capable of understanding and providing written informed consent.
- Able and willing to adhere to the study protocol.
Who cannot join
- Clinically significant abnormalities in screening assessments (physical exam, vital signs, labs, chest X-ray, ophthalmology).
- Pulmonary function: FEV1/FVC < 80% at screening.
- Positive serology for HBsAg, HCV, HIV, or TP-Ab.
- Clinically significant 12-lead ECG abnormalities or QTcF > 450 ms (male) / > 470 ms (female).
- Acute or chronic oral/pharyngeal disease.
- History or presence of significant chronic diseases of any major organ system.
Show all 27Show fewer
- History of specific diseases (glaucoma, constipation, BPH, urinary obstruction, epilepsy, hyperthyroidism, etc.).
- History of short or long QT syndrome.
- Respiratory infection within 6 weeks (lower) or 2 weeks (upper) prior to screening.
- Major surgery within 3 months prior to screening or planned during study.
- Hypersensitivity to study drug components or related drugs.
- History or evidence of drug abuse or positive drug screen.
- Excessive daily intake of tea, coffee, or caffeine (>8 cups) within 3 months prior to screening.
- Inability to refrain from certain foods/beverages containing caffeine/xanthine/glucose.
- Excessive alcohol consumption or positive alcohol screen.
- Smoking ≥5 cigarettes per day within 3 months prior to screening or positive nicotine test.
- Use of any drugs (including herbs/vitamins) within 30 days prior to screening.
- Participation in another clinical trial within 3 months prior to screening.
- Blood donation/loss (>400 mL) within 3 months prior to screening or planned during/after study.
- Difficulty with venipuncture or intolerance to intravenous access.
- History of needle or blood phobia.
- Intolerance to inhaled administration.
- Pregnancy, lactation, or positive pregnancy test.
- Unwillingness to use effective contraception during and for 6 months after the study.
- Special dietary requirements or inability to comply with standardized diet.
- Poor compliance as judged by the investigator.
- Any other condition considered unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- DBM-1152A, Placebo
- Keywords
- COPD
- 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.
DBM-1152ADrug
multiple-dose via oral inhalation nebulization
PlaceboDrug
multiple-dose of blank vehicle via oral inhalation nebulization
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Low Dose) | Experimental | DBM-1152A 1mg (1 vial of 1mg/3ml), Inhalation, QD for 7 days. Receives: Drug: DBM-1152A |
| Arm 2 (Medium Dose) | Experimental | DBM-1152A 2mg (1 vial of 2mg/3ml), Inhalation, QD for 7 days. Receives: Drug: DBM-1152A |
| Placebo | Placebo comparator | Matching placebo (solvent) administered by nebulized inhalation once daily (QD) for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety and Tolerability Profile
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
Measured: From first dose up to 7 days after last dose (Day 14).
Secondary outcomes (7)
Peak Plasma Concentration (Cmax) on Day 1
Maximum observed plasma concentration following dosing on Day 1.
Measured: Day 1: pre-dose through 24 hours post-dose.
Time to Peak Plasma Concentration (Tmax) on Day 1
Time to reach maximum observed plasma concentration on Day 1.
Measured: 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
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration on Day 1.
Measured: 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
Area under the plasma concentration-time curve from time 0 to 24 hours on Day 1.
Measured: Day 1: pre-dose through 24 hours post-dose.
Peak Plasma Concentration at Steady State (Cmax,ss) on Day 7
Maximum observed plasma concentration at steady state on Day 7.
Measured: 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 to reach maximum observed plasma concentration at steady state on Day 7.
Measured: Day 7: pre-dose through 120 hours after the last dose.
Trough Plasma Concentration at Steady State (Cmin,ss) on Day 7
Minimum observed plasma concentration at steady state on Day 7.
Measured: Day 7: pre-dose through 120 hours after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start18 Aug 2024
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439419
- Sponsor's protocol ID
- CTP-23041I-B
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07439419
- Acronym / sponsor ID
- CTP-23041I-B
- Conditions
- Healthy
- Keywords
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Livzon Pharmaceutical Group Inc.
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 27 Feb 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Low Dose) | Experimental | Drug: DBM-1152ADBM-1152A 1mg (1 vial of 1mg/3ml), Inhalation, QD for 7 days. |
| Arm 2 (Medium Dose) | Experimental | Drug: DBM-1152ADBM-1152A 2mg (1 vial of 2mg/3ml), Inhalation, QD for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo (solvent) administered by nebulized inhalation once daily (QD) for 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects.
- Aged 18 to 45 years (inclusive) at screening.
- Body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI): 19.0 - 28.0 kg/m² (inclusive).
- Capable of understanding and providing written informed consent.
- Able and willing to adhere to the study protocol.
Key exclusion criteria (27 listed)
- Clinically significant abnormalities in screening assessments (physical exam, vital signs, labs, chest X-ray, ophthalmology).
- Pulmonary function: FEV1/FVC < 80% at screening.
- Positive serology for HBsAg, HCV, HIV, or TP-Ab.
- Clinically significant 12-lead ECG abnormalities or QTcF > 450 ms (male) / > 470 ms (female).
- Acute or chronic oral/pharyngeal disease.
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-1152Amultiple-dose via oral inhalation nebulization | Drug | Arm 1 (Low Dose), Arm 2 (Medium Dose) |
| Placebomultiple-dose of blank vehicle via oral inhalation nebulization | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Peak Plasma Concentration (Cmax) on Day 1
Time frame: 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.
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 24 Hours (AUC0-24) on Day 1
Time frame: 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.
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.
Trough Plasma Concentration at Steady State (Cmin,ss) on Day 7
Time frame: Day 7: pre-dose through 120 hours after the last 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 27 Feb 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.
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 DBM-1152A in people with Healthy, 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 27 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 27 Feb 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?
Overall Safety and Tolerability Profile (time frame: From first dose up to 7 days after last dose (Day 14).). 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 27 Feb 2026.