Clinical Trial

DBM-1152A Inhalation Solution in Healthy Volunteers

Completed Phase 1
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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.
Trial Details
NCT Number NCT07439419
Lead Sponsor Joincare Pharmaceutical Group Industry Co., Ltd
Collaborators: Livzon Pharmaceutical Group Inc.
Conditions Healthy
Enrollment 20 participants
Start Date 2024-08-18
Primary Completion 2024-10-18 (estimated)
Study Completion 2024-10-18 (estimated)
Updated on ClinicalTrials.gov 2026-02-27