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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586076
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
JHL Biotech, Inc.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: JHL1922 Biological: dornase alfa Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : May 21, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: JHL1922 Biological: JHL1922
Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer
Active Comparator: Pulmozyme Biological: dornase alfa
Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer


Outcome Measures
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Primary Outcome Measures :
  1. Cmax [ Time Frame: up to 21 days ]
    Maximum observed concentration

  2. AUC0-t, [ Time Frame: up to 21 days ]
    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)

  3. AUC0-tau [ Time Frame: up to 21 days ]
    AUC over a dosing interval tau (where tau is 24 hours, calculated for the 24 hours of Day 19 only)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586076


Locations
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Netherlands
JHL Biotech Investigational Site
Groningen, Netherlands, 6 9728
Sponsors and Collaborators
JHL Biotech, Inc.
Investigators
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Principal Investigator: Sjoerd Van Marle, MD PRA Group B.V., a PRA Health Sciences company
More Information
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Responsible Party: JHL Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03586076    
Other Study ID Numbers: JHL-CLIN-1922-01
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No