A Phase 1 interventional study of JHL1922 and dornase alfa in Healthy Subjects, sponsored by JHL Biotech, Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by JHL Biotech, Inc. · Phase 1, Interventional, and Treatment
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).
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.
JHL Biotech, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: JHL1922
Biological: dornase alfa
Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer
Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer
Cmax
Maximum observed concentration
Time frame: 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)
Time frame: 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)
Time frame: up to 21 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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JHL Biotech, Inc.