NCT07439419CompletedPhase 1
DBM-1152A Inhalation Solution in Healthy Volunteers
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
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 2 Feb 2026
- Start date
- 18 Aug 2024
- Primary completion date
- 18 Oct 2024
- Lead sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
- NCT number
- NCT07439419
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 18 Aug 2024 to the primary completion date, 18 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
Other illness
- Positive serology for HBsAg, HCV, HIV, or TP-Ab.
- Acute or chronic oral/pharyngeal disease.
- History or presence of significant chronic diseases of any major organ system.
- History of specific diseases (glaucoma, constipation, BPH, urinary obstruction, epilepsy, hyperthyroidism, etc.).
- Hypersensitivity to study drug components or related drugs.
- History of needle or blood phobia.
- Any other condition considered unsuitable for participation by the investigator.
Lab values
- History of short or long QT syndrome.
- Inability to refrain from certain foods/beverages containing caffeine/xanthine/glucose.
Other
- Clinically significant abnormalities in screening assessments (physical exam, vital signs, labs, chest X-ray, ophthalmology).
- Pulmonary function: FEV1/FVC \< 80% at screening.
- Clinically significant 12-lead ECG abnormalities or QTcF \> 450 ms (male) / \> 470 ms (female).
- Excessive alcohol consumption or positive alcohol screen.
- Difficulty with venipuncture or intolerance to intravenous access.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.