NCT03586076

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

June 25, 2018

Last Update Submit

January 5, 2020

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

  • Cmax

    Maximum observed concentration

    up to 21 days

  • 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

  • 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

Study Arms (2)

JHL1922

EXPERIMENTAL
Biological: JHL1922

Pulmozyme

ACTIVE COMPARATOR
Biological: dornase alfa

Interventions

JHL1922BIOLOGICAL

Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer

JHL1922
dornase alfaBIOLOGICAL

Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer

Pulmozyme

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JHL Biotech Investigational Site

Groningen, 6 9728, Netherlands

Location

MeSH Terms

Interventions

dornase alfa

Study Officials

  • Sjoerd Van Marle, MD

    PRA Group B.V., a PRA Health Sciences company

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 13, 2018

Study Start

January 26, 2018

Primary Completion

June 22, 2018

Study Completion

May 21, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

NL(1)