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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Biological: JHL1922
* Biological: dornase alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years, inclusive Body Mass Index: 18.0-30.0 kg/m2, inclusive Weight: between 55 and 105 kg Condition: healthy; normal pulmonary function by spirometry Exclusion Criteria: - Any medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, incl. active, or history of, pulmonary disorders incl. asthma or chronic obstructive pulmonary disease (COPD)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JHL1922<br> | Biological: JHL1922<br>* Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer<br>|
| Active Comparator: Pulmozyme<br> | Biological: dornase alfa<br>* Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed concentration | 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) | 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) | up to 21 days |