DBM-1152A Inhalation Solution in Healthy Volunteers

NCT07439419 | Completed Phase 1

• 1 other identifier: CTP-23041I-B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Peak Plasma Concentration (Cmax) on Day 1

  Day 1: pre-dose through 24 hours post-dose.

• Time to Peak Plasma Concentration (Tmax) 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

  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

  Day 1: pre-dose through 24 hours post-dose.

• Peak Plasma Concentration at Steady State (Cmax,ss) on Day 7

  Day 7: pre-dose through 120 hours after the last dose.

Study Arms (3)

Arm 1 (Low Dose)

EXPERIMENTAL

DBM-1152A 1mg (1 vial of 1mg/3ml), Inhalation, QD for 7 days.

Drug: DBM-1152A

Arm 2 (Medium Dose)

EXPERIMENTAL

DBM-1152A 2mg (1 vial of 2mg/3ml), Inhalation, QD for 7 days.

Drug: DBM-1152A

Placebo

PLACEBO COMPARATOR

Matching placebo (solvent) administered by nebulized inhalation once daily (QD) for 7 days.

Drug: Placebo

Interventions

DBM-1152A DRUG

multiple-dose via oral inhalation nebulization

Arm 1 (Low Dose); Arm 2 (Medium Dose)

Placebo DRUG

multiple-dose of blank vehicle via oral inhalation nebulization

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This pharmacokinetic study requires controlling for biological sex (assigned at birth) as a variable due to its potential influence on drug metabolism and exposure. Therefore, eligibility is based on sex assigned at birth (recorded as male or female), which will be verified during screening through participant-provided medical history and/or clinical assessment. We acknowledge and respect all gender identities. Individuals whose biological sex aligns with the study's sex-based criteria are eligible to participate, regardless of their gender identity (e.g., transgender men, transgender women, non-binary, or gender-diverse individuals).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects.
• Aged 18 to 45 years (inclusive) at screening.
• Body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI): 19.0 - 28.0 kg/m² (inclusive).
• Capable of understanding and providing written informed consent.
• Able and willing to adhere to the study protocol.

You may not qualify if:

• Clinically significant abnormalities in screening assessments (physical exam, vital signs, labs, chest X-ray, ophthalmology).
• Pulmonary function: FEV1/FVC \< 80% at screening.
• Positive serology for HBsAg, HCV, HIV, or TP-Ab.
• Clinically significant 12-lead ECG abnormalities or QTcF \> 450 ms (male) / \> 470 ms (female).
• Acute or chronic oral/pharyngeal disease.
• History or presence of significant chronic diseases of any major organ system.
• History of specific diseases (glaucoma, constipation, BPH, urinary obstruction, epilepsy, hyperthyroidism, etc.).
• History of short or long QT syndrome.
• Respiratory infection within 6 weeks (lower) or 2 weeks (upper) prior to screening.
• Major surgery within 3 months prior to screening or planned during study.
• Hypersensitivity to study drug components or related drugs.
• History or evidence of drug abuse or positive drug screen.
• Excessive daily intake of tea, coffee, or caffeine (\>8 cups) within 3 months prior to screening.
• Inability to refrain from certain foods/beverages containing caffeine/xanthine/glucose.
• Excessive alcohol consumption or positive alcohol screen.

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

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 27, 2026
• Study Start: August 18, 2024
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)