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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer
Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer
JHL Biotech Investigational Site
Groningen, Netherlands
Cmax
Maximum observed concentration
Time frame: up to 21 days
AUC0-t,
Area under the concentration-time curve (AUC) up to time t, where t is the last point with concentrations above the lower limit of quantitation (calculated for single-dose treatments only)
Time frame: up to 21 days
AUC0-tau
AUC over a dosing interval tau (where tau is 24 hours, calculated for the 24 hours of Day 19 only)
Time frame: up to 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.