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| Name | Class |
|---|---|
| Livzon Pharmaceutical Group Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg DBM-1152A | Experimental | Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label) |
|
| 2 mg DBM-1152A | Experimental | Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution. |
|
| 4 mg DBM-1152A | Experimental | Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution |
|
| 6 mg DBM-1152A | Experimental | Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution. |
|
| 9 mg DBM-1152A | Experimental | Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution. |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBM-1152A Inhalation Solution | Drug | Single dose via oral inhalation nebulization. |
|
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanmin Wu | Xuzhou Central Hospital | Principal Investigator |
| 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 |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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The 1 mg cohort is open-label. The 2 mg, 4 mg, 6 mg, and 9 mg cohorts are double-blind.
Participants receive a single dose of matching placebo (blank vehicle) corresponding to the 2 mg, 4 mg, 6 mg, or 9 mg cohorts. |
|
| Placebo | Drug | Single dose of blank vehicle via oral inhalation nebulization. |
|
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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |