NCT03586076

A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects

A Double-Blind Randomised 2-Arm, 2-Period Crossover Study to Access the Similarity of Safety and Pharmacokinetics of JHL1922 and Pulmozyme® After Single and Repeated Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: JHL Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomised, 2 single-doses and then repeated-dose (5 days), 2-arm, 2-period crossover phase 1 study in 24 healthy male or female subjects. Subjects will be randomised to one of two treatment sequences in 2 treatment periods: JHL1922 (test treatment) first and then Pulmozyme (reference treatment) or Pulmozyme (reference treatment) first and then JHL1922 (test treatment).

Detailed description

All 24 subjects will receive either JHL1922 or Pulmozyme as single doses of 2.5 mg and then 10 mg per eRapid nebulizer, followed after a washout by a 5-period of daily dosing of 10 mg of either JHL1922 or Pulmozyme per eRapid nebulizer. The primary objective is to assess the similarity of safety and tolerability of test products, and the exploratory objective is to assess the similarity, if possible, of the systemic levels and sputum levels of dornase alfa after administration of test products.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	JHL1922	Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer
BIOLOGICAL	dornase alfa	Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer

Timeline

• Start date: 2018-01-26
• Primary completion: 2018-06-22
• Completion: 2019-05-21
• First posted: 2018-07-13
• Last updated: 2020-01-07

Locations

1 site across 1 country: Netherlands