Health, Health Adult Subjects
Conditions
Keywords
COPD, Asthma
Brief summary
This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects.
Interventions
DRUGDBM-1152A Inhalation Solution
Single dose via oral inhalation nebulization.
DRUGPlacebo
Single 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)
Masking description
The 1 mg cohort is open-label. The 2 mg, 4 mg, 6 mg, and 9 mg cohorts are double-blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese healthy male or female subjects. 2. Age 18 to 45 years (inclusive). 3. Body weight: Male ≥50.0kg, Female≥45.0 kg; BMI within the range of 19.0 to 26.0 kg/m\^2 (inclusive). 4. Subjects (including their partners) are willing to use effective contraception from the screening period until 6 months after the last dose. 5. Subjects must fully understand the study, participate voluntarily, and sign the written informed consent.
Exclusion criteria
1. Clinically significant abnormalities in physical examination, chest X-ray, hematology, urinalysis, blood biochemistry, coagulation function, thyroid function, or ophthalmic examination during screening; or FEV1/FVC \< 80% in pulmonary function tests. 2. Positive results in virology screening (HBsAg, anti-HCV, anti-HIV, or TP-Ab). 3. Abnormal vital signs at screening: Sitting systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, diastolic blood pressure \< 55 mmHg or ≥ 90 mmHg; Pulse \< 50 bpm or \> 90 bpm; Body temperature \< 35.9°C or \> 37.6°C; Respiratory rate \< 12 breaths/min or \> 20 breaths/min. 4. Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTc): Male ≥ 450 ms, Female ≥ 470 ms. 5. Electrolyte or glucose abnormalities at screening: Hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia, or hyperglycemia. 6. Current acute or chronic oral or pharyngeal diseases (e.g., oral ulcers, pharyngitis). 7. History or presence of chronic or severe diseases in the endocrine, urinary, digestive, hematological, respiratory, cardiovascular, neuropsychiatric, or immune systems, or any other physiological condition that may interfere with the study results. 8. History or presence of glaucoma, functional constipation, prostatic hyperplasia, urinary tract obstruction, urinary retention, epilepsy, hyperthyroidism, paradoxical bronchospasm, diabetes, or ketoacidosis. 9. History or presence of Short QT Syndrome or Long QT Syndrome. 10. Lower respiratory tract infection within 6 weeks prior to screening, or clinically significant upper respiratory tract disease within 2 weeks prior to screening. 11. Surgery within 3 months prior to screening, especially procedures affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study. 12. Suspected allergy to DBM-1152A or its excipients; history of hypersensitivity to other anticholinergic drugs or β2-agonists; or history of significant food or drug allergies. 13. History of drug abuse or drug dependence within 12 months prior to screening. 14. Positive drug screening (morphine, methamphetamine, ketamine, MDMA, or THC) prior to enrollment. 15. Excessive consumption of tea, coffee, or caffeinated beverages (≥8 cups/day, 250mL/cup) within the past 6 months; or consumption of caffeine-rich or grapefruit-rich food/beverages within 48 hours prior to screening. 16. History of alcohol abuse within the past 12 months (Male ≥ 28 units/week, Female ≥ 21 units/week); or regular drinking (≥14 units/week) within 6 months prior to screening; or inability to abstain from alcohol during the study. 17. Positive breath alcohol test (\> 0 mg/100 mL) prior to enrollment. 18. Current smoker or history of smoking. 19. Positive nicotine test prior to enrollment. 20. Use of any medications (including prescription, OTC, vitamins, herbal medicine, supplements, or vaccines) within 30 days prior to screening. 21. Participation in any clinical trial of a drug or device within 3 months prior to screening. 22. Blood donation or significant blood loss (\> 400 mL) within 3 months prior to screening; or planned blood donation during or within 3 months after the study. 23. Difficulty in venous blood collection or inability to tolerate venipuncture. 24. History of needle syncope or blood syncope. 25. Inability to tolerate inhalation administration. 26. Strenuous exercise within 48 hours prior to screening. 27. Pregnant or lactating women, or women planning pregnancy; use of long-acting estrogen/progestogen injections or implants within 6 months prior to screening; or positive pregnancy test. 28. Male subjects (or their partners) or female subjects planning pregnancy, sperm donation, or egg donation within 6 months after the study, or unwilling to use contraception. 29. Special dietary requirements or inability to comply with the standardized diet. 30. Poor compliance. 31. Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability | From informed consent up to Day 4 (End of study). | Safety and tolerability are evaluated through adverse events (AEs), vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), 12-lead ECG, Holter monitoring, and pupil examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Maximum observed plasma concentration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Area under the plasma concentration versus time curve from time 0 extrapolated to infinity. |
| Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Time to reach maximum observed plasma concentration. |
| Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Apparent terminal elimination half-life. |
| Apparent Total Plasma Clearance (CL/F) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Apparent total plasma clearance calculated as dose divided by AUC0-∞. |
| Apparent Volume of Distribution (Vz/F) of DBM-1152A | Pre-dose (within 1 hour before dosing) up to 72 hours post-dose. | Apparent volume of distribution during the terminal phase. |
| Cumulative Amount of DBM-1152A Excreted Unchanged in Urine (Ae) (6 mg Cohort Only) | Pre-dose (within 24 hours before dosing) up to 72 hours post-dose. | Cumulative amount of unchanged drug excreted in the urine. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYanmin Wu
Xuzhou Central Hospital
Outcome results
None listed