Trials / Completed
CompletedNCT03748199
Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF
Phase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Santhera Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
"This is a randomised, double-blind, placebo-controlled multi-centre study to investigate safety and tolerability and to provide pharmacokinetic and pharmacodynamics information of orally inhaled multiple doses (80 mg, 160 mg or 320 mg) of the nebulised neutrophil elastase inhibitor POL6014 in patients with Cystic Fibrosis. The controlled inhalation will occur via the eFlow® nebuliser system (manufacturer: PARI Pharma GmbH, Germany)".
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | POL6014 | DL1 80 mg cohorts 1A and 1B (80 mg QD and 40 mg BID) DL2 160 mg cohorts 2A and 2B (160 mg QD and 80 mg BID) DL3 40 mg QD cohort C DL = dose Level QD= quaque die (once daily) BID= bis in die (twice daily) |
| DRUG | Placebo | Placebo will be administered orally at a dose and frequency matched to POL6014 |
Timeline
- Start date
- 2018-11-08
- Primary completion
- 2020-12-30
- Completion
- 2020-12-30
- First posted
- 2018-11-20
- Last updated
- 2021-09-28
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03748199. Inclusion in this directory is not an endorsement.