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

Sponsor

JHL Biotech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03586076

Collaborator

(none)

Enrollment

Location

Arms

15.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 26, 2018

Actual Primary Completion Date :

Jun 22, 2018

Actual Study Completion Date :

May 21, 2019

Arms and Interventions

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

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

Primary Outcome Measures

Cmax [up to 21 days]
Maximum observed concentration
AUC0-t, [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 [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

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	JHL Biotech Investigational Site	Groningen		Netherlands	6 9728

Sponsors and Collaborators

JHL Biotech, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JHL Biotech, Inc.

ClinicalTrials.gov Identifier:

NCT03586076

Other Study ID Numbers:

JHL-CLIN-1922-01

First Posted:

Jul 13, 2018

Last Update Posted:

Jan 7, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 7, 2020