A DOUBLE-BLIND RANDOMISED 2-ARM, 2-PERIOD CROSSOVER STUDY TO ASSESS THE SIMILARITY OF SAFETY AND PHARMACOKINETICS OF JHL1922 AND PULMOZYME® AFTER SINGLE AND REPEATED ADMINISTRATION IN HEALTHY SUBJECTS

A DOUBLE-BLIND RANDOMISED 2-ARM, 2-PERIOD CROSSOVER STUDY TO ASSESS THE SIMILARITY OF SAFETY AND PHARMACOKINETICS OF JHL1922 AND PULMOZYME® AFTER SINGLE AND REPEATED ADMINISTRATION IN HEALTHY SUBJECTS - Comparative safety and PK study of JHL1922 and Pulmozyme®

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46758

Enrollment

Registered

2018-01-08

Start date

2018-01-26

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary disorders

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male/female 18 - 70 years (BMI) 18 t/m 30 kilograms/meter2 55 - 105 kg non smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To assess the similarity of safety and tolerability of the test product, JHL1922 (dornase alfa biosimilar), and the reference product, Pulmozyme, at single doses of 2.5 mg and 10 mg of dornase alfa and after 5 days of repeated daily doses of 10 mg, administered per eRapid* nebulizer system.	—

Secondary

Measure	Time frame
To assess the similarity, if possible, of the systemic levels and sputum levels of dornase alfa after administration of the test product, JHL1922 (dornase alfa biosimilar), and the reference product, Pulmozyme, at single doses of 2.5 mg or 10 mg of dornase alfa and after 5 days of repeated daily doses of 10 mg, administered per eRapid* nebulizer.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)