Trials / Completed
CompletedNCT02866825
Studying Complement Inhibition in Complex Cardiac Surgery
A Phase II Randomized, Placebo-controlled, Double-blind, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamic Dose Response Relationship of IFX-1 in Patients Undergoing Complex Cardiac Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- InflaRx GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal antibody IFX-1 in these patients. In addition, this trial further aims to characterize the safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on clinical surrogate endpoints.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IFX-1 | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2016-12-01
- Completion
- 2017-01-01
- First posted
- 2016-08-15
- Last updated
- 2017-02-15
Locations
10 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02866825. Inclusion in this directory is not an endorsement.