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| Name | Class |
|---|---|
| Livzon Pharmaceutical Group Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Low Dose) | Experimental | DBM-1152A 1mg (1 vial of 1mg/3ml), Inhalation, QD for 7 days. |
|
| Arm 2 (Medium Dose) | Experimental | DBM-1152A 2mg (1 vial of 2mg/3ml), Inhalation, QD for 7 days. |
|
| Placebo | Placebo Comparator | Matching placebo (solvent) administered by nebulized inhalation once daily (QD) for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBM-1152A | Drug | multiple-dose via oral inhalation nebulization |
|
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
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.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo | Drug | multiple-dose of blank vehicle via oral inhalation nebulization |
|
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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |