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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Biological: dornase alfa; Biological: JHL1922

• Registration Number: NCT03586076
• Lead Sponsor: JHL Biotech, Inc.

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 Timeline

• Study Start: 2018-01-26
• Primary Completion: 2018-06-22
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-13
• Study Completion: 2019-05-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pulmozyme	dornase alfa	-
JHL1922	JHL1922	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

JHL Biotech Investigational Site; 🇳🇱 Groningen, Netherlands