NCT07439419

DBM-1152A Inhalation Solution in Healthy Volunteers

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of DBM-1152A Inhalation Solution in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DBM-1152A	multiple-dose via oral inhalation nebulization
DRUG	Placebo	multiple-dose of blank vehicle via oral inhalation nebulization

Timeline

• Start date: 2024-08-18
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China