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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586076
• Other study ID #: JHL-CLIN-1922-01
• Status: Completed
• Phase: Phase 1
• Start date: January 26, 2018
• Est. completion date: May 21, 2019

Study information

• Verified date: January 2020
• Source: JHL Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 21, 2019
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• JHL1922
Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer
• dornase alfa
Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer

Locations

Country	Name	City	State
Netherlands	JHL Biotech Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
JHL Biotech, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum observed concentration	up to 21 days
Primary	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
Primary	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