NCT06958861

A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of inhaled H057 in the treatment of acute exacerbations of bronchiectasis.

Conditions

• Acute Exacerbations of Bronchiectasis

Interventions

Type	Name	Description
DRUG	Low-dose H057+standard-of-care	Subjects are administered low-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
DRUG	High-dose H057+standard-of-care	Subjects are administered high-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
DRUG	H057 placebo+standard-of-care	Subjects are administered inhaled H057 placebo, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-05-06
• Last updated: 2025-05-09

Locations

19 sites across 1 country: China