DBM-1152A Inhalation Solution in Healthy Volunteers

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.