DBM-1152A Inhalation Solution in Chinese Healthy Subjects

A Randomized, Double-blind, Single-center, Placebo-controlled, Dose-escalation Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of DBM-1152A Inhalation Solution in Chinese Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Health; Health Adult Subjects
• Intervention / Treatment: Drug: DBM-1152A Inhalation Solution; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Xuzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 mg DBM-1152A; Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label)	Drug: DBM-1152A Inhalation Solution; Single dose via oral inhalation nebulization.
Experimental: 2 mg DBM-1152A; Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution.	Drug: DBM-1152A Inhalation Solution; Single dose via oral inhalation nebulization.
Experimental: 4 mg DBM-1152A; Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution	Drug: DBM-1152A Inhalation Solution; Single dose via oral inhalation nebulization.
Experimental: 6 mg DBM-1152A; Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution.	Drug: DBM-1152A Inhalation Solution; Single dose via oral inhalation nebulization.
Experimental: 9 mg DBM-1152A; Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution.	Drug: DBM-1152A Inhalation Solution; Single dose via oral inhalation nebulization.
Placebo Comparator: Placebo; Participants receive a single dose of matching placebo (blank vehicle) corresponding to the 2 mg, 4 mg, 6 mg, or 9 mg cohorts.	Drug: Placebo; Single dose of blank vehicle via oral inhalation nebulization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability	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.	From informed consent up to Day 4 (End of study).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of DBM-1152A	Maximum observed plasma concentration.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of DBM-1152A	Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of DBM-1152A	Area under the plasma concentration versus time curve from time 0 extrapolated to infinity.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A	Time to reach maximum observed plasma concentration.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A	Apparent terminal elimination half-life.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Total Plasma Clearance (CL/F) of DBM-1152A	Apparent total plasma clearance calculated as dose divided by AUC0-∞.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Volume of Distribution (Vz/F) of DBM-1152A	Apparent volume of distribution during the terminal phase.	Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Cumulative Amount of DBM-1152A Excreted Unchanged in Urine (Ae) (6 mg Cohort Only)	Cumulative amount of unchanged drug excreted in the urine.	Pre-dose (within 24 hours before dosing) up to 72 hours post-dose.

Collaborators and Investigators

• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd
• Collaborators: Livzon Pharmaceutical Group Inc.
• Investigators: Principal Investigator: Yanmin Wu, Xuzhou Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2023
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: CTP-23041I-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No