Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE January 26, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Cmax [ Time Frame: up to 21 days ]
    Maximum observed concentration
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Cmax [ Time Frame: up to 21 days ]
  • AUC0-t, [ Time Frame: up to 21 days ]
  • AUC0-tau [ Time Frame: up to 21 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: JHL1922
    Intervention: Biological: JHL1922
  • Active Comparator: Pulmozyme
    Intervention: Biological: dornase alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 21, 2019
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03586076
Other Study ID Numbers  ICMJE JHL-CLIN-1922-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party JHL Biotech, Inc.
Study Sponsor  ICMJE JHL Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sjoerd Van Marle, MD PRA Group B.V., a PRA Health Sciences company
PRS Account JHL Biotech, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP