Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CaCP29 · 1 trial · 2 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
| 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 | - |
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 an investigational monoclonal antibody studied for drug safety and severe sepsis. It was evaluated in a Phase 2 clinical trial for patients with severe sepsis or septic shock, and in a Phase 1 trial in healthy male volunteers to assess safety and tolerability.
CaCP29 is being developed by InflaRx N.V., a biopharmaceutical company traded on the NASDAQ under the ticker IFRX.
CaCP29 is in Phase 2 clinical development. It has completed a Phase 2 trial studying complement inhibition in early, newly developing septic organ dysfunction, and a Phase 1 trial assessing safety and tolerability.
CaCP29 has been studied in two completed clinical trials: NCT01319903, a Phase 1 safety and tolerability study in healthy male volunteers in Germany, and NCT02246595, a Phase 2 trial in patients with severe sepsis or septic shock in Germany.
No, CaCP29 is a distinct investigational monoclonal antibody developed by InflaRx. It is not the same as IFX-1, which is a separate drug candidate in the company's pipeline.