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Completed

NCT Number: NCT03586076

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

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).

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Key information

Conditions

Healthy Subjects

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

JHL Biotech Investigational Site

Groningen, 6 9728, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

JHL1922

Biological

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

dornase alfa

Biological

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

Primary outcomes

  1. Cmax

    Time frame: up to 21 days

    Maximum observed concentration

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

JHL Biotech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 13, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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