DBM-1152A Inhalation Solution in Chinese Healthy Subjects

NCT07447141 | Completed Phase 1

• 1 other identifier: CTP-23041I-A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Health; Health Adult Subjects

Keywords

COPD; Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Peak Plasma Concentration (Cmax) of DBM-1152A

  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

  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

  Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

• Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A

  Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

• Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A

  Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.

Study Arms (6)

1 mg DBM-1152A

EXPERIMENTAL

Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label)

Drug: DBM-1152A Inhalation Solution

2 mg DBM-1152A

EXPERIMENTAL

Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution.

Drug: DBM-1152A Inhalation Solution

4 mg DBM-1152A

EXPERIMENTAL

Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution

Drug: DBM-1152A Inhalation Solution

6 mg DBM-1152A

EXPERIMENTAL

Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution.

Drug: DBM-1152A Inhalation Solution

9 mg DBM-1152A

EXPERIMENTAL

Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution.

Drug: DBM-1152A Inhalation Solution

Placebo

PLACEBO COMPARATOR

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

Interventions

DBM-1152A Inhalation Solution DRUG

Single dose via oral inhalation nebulization.

1 mg DBM-1152A; 2 mg DBM-1152A; 4 mg DBM-1152A; 6 mg DBM-1152A; 9 mg DBM-1152A

Placebo DRUG

Single dose of blank vehicle via oral inhalation nebulization.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy male or female subjects.
• Age 18 to 45 years (inclusive).
• Body weight: Male ≥50.0kg, Female≥45.0 kg; BMI within the range of 19.0 to 26.0 kg/m\^2 (inclusive).
• Subjects (including their partners) are willing to use effective contraception from the screening period until 6 months after the last dose.
• Subjects must fully understand the study, participate voluntarily, and sign the written informed consent.

You may not qualify if:

• 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.
• Positive results in virology screening (HBsAg, anti-HCV, anti-HIV, or TP-Ab).
• 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.
• Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTc): Male ≥ 450 ms, Female ≥ 470 ms.
• Electrolyte or glucose abnormalities at screening: Hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia, or hyperglycemia.
• Current acute or chronic oral or pharyngeal diseases (e.g., oral ulcers, pharyngitis).
• 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.
• History or presence of glaucoma, functional constipation, prostatic hyperplasia, urinary tract obstruction, urinary retention, epilepsy, hyperthyroidism, paradoxical bronchospasm, diabetes, or ketoacidosis.
• History or presence of Short QT Syndrome or Long QT Syndrome.
• Lower respiratory tract infection within 6 weeks prior to screening, or clinically significant upper respiratory tract disease within 2 weeks prior to screening.
• Surgery within 3 months prior to screening, especially procedures affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study.
• 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.
• History of drug abuse or drug dependence within 12 months prior to screening.
• Positive drug screening (morphine, methamphetamine, ketamine, MDMA, or THC) prior to enrollment.
• 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.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead
• Livzon Pharmaceutical Group Inc.: collaborator

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yanmin Wu

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The 1 mg cohort is open-label. The 2 mg, 4 mg, 6 mg, and 9 mg cohorts are double-blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: March 3, 2026
• Study Start: December 24, 2023
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)