Moderate to Severe Chronic Spontaneous Urticaria (CSU) or Moderate to Severe Hidradenitis Suppurativa (HS)
Conditions
Brief summary
Frequency, severity, and relatedness of treatment- emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification.
Detailed description
Plasma PK parameters of INF904 calculated as appropriate: • Maximum observed plasma concentrations (Cmax), • Minimum observed plasma concentration (Cmin), • Time of occurrence of maximum plasma concentration (tmax), • Systemic exposure, defined as the Area Under Curve AUC0-24, AUClast, PK parameters may also be derived from a Population PK (PopPK) model including AUCinf, AUC0--12 hr, AUC0-24 hr, Cmax, tmax, terminal half-life (t½), terminal elimination phase (Vz/F), and apparent oral clearance (CL/F).
Interventions
DRUGINF904
Sponsors
InflaRx GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, severity, and relatedness of treatment- emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PK parameters of INF904 calculated as appropriate: • Maximum observed plasma concentrations (Cmax), • Minimum observed plasma concentration (Cmin), • Time of occurrence of maximum plasma concentration (tmax), • Systemic exposure, defined as the Area Under Curve AUC0-24, AUClast, PK parameters may also be derived from a Population PK (PopPK) model including AUCinf, AUC0--12 hr, AUC0-24 hr, Cmax, tmax, terminal half-life (t½), terminal elimination phase (Vz/F), and apparent oral clearance (CL/F). | — |
Countries
Bulgaria, Germany, Greece, Poland
Outcome results
None listed