A Phase 1 interventional study of DBM-1152A Inhalation Solution and Placebo in Health and Health Adult Subjects, sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Joincare Pharmaceutical Group Industry Co., Ltd · Phase 1, Interventional, and Treatment
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Joincare Pharmaceutical Group Industry Co., Ltd is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive a single dose of 1 mg DBM-1152A Inhalation Solution. (Sentinel cohort, open-label)
Drug: DBM-1152A Inhalation Solution
Participants receive a single dose of 2 mg DBM-1152A Inhalation Solution.
Drug: DBM-1152A Inhalation Solution
Participants receive a single dose of 4 mg DBM-1152A Inhalation Solution
Drug: DBM-1152A Inhalation Solution
Participants receive a single dose of 6 mg DBM-1152A Inhalation Solution.
Drug: DBM-1152A Inhalation Solution
Participants receive a single dose of 9 mg DBM-1152A Inhalation Solution.
Drug: DBM-1152A Inhalation Solution
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
Single dose via oral inhalation nebulization.
Single dose of blank vehicle via oral inhalation nebulization.
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.
Time frame: From informed consent up to Day 4 (End of study).
Peak Plasma Concentration (Cmax) of DBM-1152A
Maximum observed plasma concentration.
Time frame: 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
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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-∞.
Time frame: 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.
Time frame: 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.
Time frame: Pre-dose (within 24 hours before dosing) up to 72 hours post-dose.
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Joincare Pharmaceutical Group Industry Co., Ltd