Trials / Completed
CompletedNCT02246595
Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction
A Phase II Randomized, Placebo-controlled, Double-blind, Dose Controlled Trial in Patients Suffering From Early, Newly Developing Abdominal or Pulmonary Derived Septic Organ Dysfunction to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and to Estimate Efficacy of the New Humanized Monoclonal i.v. Administered Antibody CaCP29
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- InflaRx GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CaCP29 | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-09-23
- Last updated
- 2016-04-25
Locations
11 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02246595. Inclusion in this directory is not an endorsement.