drugset / Trial / NCT03586076
A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects
RandomizedCrossoverDouble-blindTreatment
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).
Timeline
- Start
- 2018-01-26
- Primary completion
- 2018-06-22
- Completion
- 2019-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JHL1922 | Unknown | 10 mg | Other |
| Comparator | dornase alfa | Protein / enzyme biologic | 10 mg | Other |
Indications
No indication recorded.