Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01319903 | Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29 | PHASE1 | COMPLETED | 26 | — | — | Mar 1, 2011 | Oct 1, 2011 | Jan 13, 2012 | 1 | Germany |
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 \...