Healthy Subjects Clinical Trial
Official title:
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
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).
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.
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