Healthy
Conditions
Keywords
COPD
Brief 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. 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.
Interventions
DRUGDBM-1152A
multiple-dose via oral inhalation nebulization
DRUGPlacebo
multiple-dose of blank vehicle via oral inhalation nebulization
Sponsors
Joincare Pharmaceutical Group Industry Co., Ltd
Livzon Pharmaceutical Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Safety and Tolerability Profile | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) 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 on Day 1. |
| Peak Plasma Concentration (Cmax) on Day 1 | Day 1: pre-dose through 24 hours post-dose. | Maximum observed plasma concentration following dosing on Day 1. |
| Time to Peak Plasma Concentration (Tmax) on Day 1 | Day 1: pre-dose through 24 hours post-dose. | Time to reach maximum observed plasma concentration on Day 1. |
| Peak Plasma Concentration at Steady State (Cmax,ss) on Day 7 | Day 7: pre-dose through 120 hours after the last dose. | Maximum observed plasma concentration at steady state on Day 7. |
| Time to Peak Plasma Concentration at Steady State (Tmax,ss) on Day 7 | Day 7: pre-dose through 120 hours after the last dose. | Time to reach maximum observed plasma concentration at steady state on Day 7. |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) on Day 1 | 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. |
| Trough Plasma Concentration at Steady State (Cmin,ss) on Day 7 | Day 7: pre-dose through 120 hours after the last dose. | Minimum observed plasma concentration at steady state on Day 7. |
Countries
China
Outcome results
None listed