drugset / Trial / NCT05722938
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.
Timeline
- Start
- 2023-09-09
- Primary completion
- 2028-07-31
- Completion
- 2028-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trimodulin | Protein / enzyme biologic | — | Intravenous |