Inflammatory mediated immune diseases
Conditions
Brief summary
This objective is measured by whole body PET-CT imaging 24 hours (D2) after IP administration. In addition to visual assessment, uptake of [89Zr]-DFO-CIT-013 will be quantified per organ(-system). In vivo distribution profiles will be evaluated per cohort to determine ranges of uptake per organ(-system) and between cohorts to compare uptake in different IMIDs.
Detailed description
Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs., Pharmacokinetic (PK) levels throughout the trial, per cohort.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This objective is measured by whole body PET-CT imaging 24 hours (D2) after IP administration. In addition to visual assessment, uptake of [89Zr]-DFO-CIT-013 will be quantified per organ(-system). In vivo distribution profiles will be evaluated per cohort to determine ranges of uptake per organ(-system) and between cohorts to compare uptake in different IMIDs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAE) throughout the trial period, including clinically relevant findings and ADAs., Pharmacokinetic (PK) levels throughout the trial, per cohort. | — |
Countries
Netherlands