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CaCP29, a humanized monoclonal antibody · 1 trial · 1 indication
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
| Name | Type | Description |
|---|---|---|
| CaCP29, a humanized monoclonal antibody | BIOLOGICAL | CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males |
Inclusion Criteria: * Male, Caucasian subjects aged between 18-40 years (inclusive) * Healthy subjects as determined by medical history, physical examination * Body weight between 70 - 100 kg and BMI between 19 and 29 kg/m2, extremes incl * ECG recording based on a 12-lead ECG which is normal (PR \...
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.