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

• ClinicalTrials.gov Identifier: NCT03586076
• Recruitment Status: Completed
• First Posted: July 13, 2018
• Last Update Posted: January 7, 2020
• Sponsor: JHL Biotech, Inc.
• Information provided by (Responsible Party): JHL Biotech, Inc.

Tracking Information

• First Submitted Date: June 25, 2018
• First Posted Date: July 13, 2018
• Last Update Posted Date: January 7, 2020
• Actual Study Start Date: January 26, 2018
• Actual Primary Completion Date: June 22, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Healthy Subjects

Intervention

• 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

• Experimental: JHL1922
  Intervention: Biological: JHL1922
• Active Comparator: Pulmozyme
  Intervention: Biological: dornase alfa

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 12, 2018): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 21, 2019
• Actual Primary Completion Date: June 22, 2018 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT03586076
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: JHL Biotech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: JHL Biotech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sjoerd Van Marle, MD; PRA Group B.V., a PRA Health Sciences company

• PRS Account: JHL Biotech, Inc.
• Verification Date: January 2020