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Also known as CaCP29
CaCP29, a humanized monoclonal antibody · 2 trials · 3 indications
Pharmacokinetic measures include * Plasma concentration over time * Maximum observed concentration per infusion * Concentration measured immediately before next dosing * Area under the curve of plasma concentration per infusion * Mean concentration per infusion * Terminal phase half-life
Safety relevant parameters include changes from baseline of: * cytokine levels over time (IL-6, IL-8, IFN-gamma, TNF-alpha, IL-10) * CH50 activity over time * standard hematology, clinical chemistry and coagulation laboratory parameters * 12-lead ECG * vital signs
| Arm | Type | Description |
|---|---|---|
| CaCP29 | ACTIVE_COMPARATOR | dose escalating i.v. administration of CaCP29 (verum) |
| Placebo | PLACEBO_COMPARATOR | dose escalation mimicing i.v. placebo treatment: |
| Name | Type | Description |
|---|---|---|
| CaCP29 | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| CaCP29, a humanized monoclonal antibody | BIOLOGICAL | CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males |
Key Inclusion Criteria at screening: 1. Male or female patients \>= 18 years old 2. Written informed consent 3. Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening...
CaCP29 is a humanized monoclonal antibody developed by InflaRx N.V. as an investigational therapy. It has been studied in clinical trials for drug safety in healthy volunteers and for severe sepsis and septic shock. It is not an approved medicine and remains in clinical development.
CaCP29 has been studied as a potential treatment for severe sepsis and septic shock, specifically in patients with early, newly developing septic organ dysfunction. The Phase 2 study NCT02246595 enrolled 72 adults in Germany. No approved indication exists for CaCP29, and it remains investigational.
CaCP29 is developed by InflaRx N.V., a biopharmaceutical company whose shares trade under the ticker IFRX. InflaRx sponsored the clinical program evaluating the antibody in healthy volunteers and in patients with severe sepsis and septic shock.
CaCP29 has completed a Phase 1 study and a Phase 2 study. The Phase 1 trial NCT01319903 assessed safety and tolerability in 26 healthy male volunteers, and the Phase 2 trial NCT02246595 studied complement inhibition in early septic organ dysfunction. CaCP29 is investigational and has not been approved by the FDA.
Two completed trials have evaluated CaCP29. NCT01319903 was a Phase 1 clinical assessment of safety and tolerability in 26 healthy male volunteers in Germany. NCT02246595 was a Phase 2 study of complement inhibition in early, newly developing septic organ dysfunction, enrolling 72 adults in Germany.
Yes. CaCP29 and the description "CaCP29, a humanized monoclonal antibody" refer to the same investigational antibody developed by InflaRx N.V. CaCP29 is the compound name used across its clinical program, including the Phase 1 and Phase 2 trials conducted in Germany.