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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DBM-1152A; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• 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. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (Low Dose); DBM-1152A 1mg (1 vial of 1mg/3ml), Inhalation, QD for 7 days.	Drug: DBM-1152A; multiple-dose via oral inhalation nebulization
Experimental: Arm 2 (Medium Dose); DBM-1152A 2mg (1 vial of 2mg/3ml), Inhalation, QD for 7 days.	Drug: DBM-1152A; multiple-dose via oral inhalation nebulization
Placebo Comparator: Placebo; Matching placebo (solvent) administered by nebulized inhalation once daily (QD) for 7 days.	Drug: Placebo; multiple-dose of blank vehicle via oral inhalation nebulization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Safety and Tolerability Profile	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	From first dose up to 7 days after last dose (Day 14).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) on Day 1	Maximum observed plasma concentration following dosing on Day 1.	Day 1: pre-dose through 24 hours post-dose.
Time to Peak Plasma Concentration (Tmax) on Day 1	Time to reach maximum observed plasma concentration on Day 1.	Day 1: pre-dose through 24 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) on Day 1	Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration 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 (AUC0-24) on Day 1	Area under the plasma concentration-time curve from time 0 to 24 hours on Day 1.	Day 1: pre-dose through 24 hours post-dose.
Peak Plasma Concentration at Steady State (Cmax,ss) on Day 7	Maximum observed plasma concentration at steady state on Day 7.	Day 7: pre-dose through 120 hours after the last dose.
Time to Peak Plasma Concentration at Steady State (Tmax,ss) on Day 7	Time to reach maximum observed plasma concentration at steady state on Day 7.	Day 7: pre-dose through 120 hours after the last dose.
Trough Plasma Concentration at Steady State (Cmin,ss) on Day 7	Minimum observed plasma concentration at steady state on Day 7.	Day 7: pre-dose through 120 hours after the last dose.

Collaborators and Investigators

• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd
• Collaborators: Livzon Pharmaceutical Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2024
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

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

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