The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
This is a Phase 1b, open-label study evaluating the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
cizutamig will be dosed SC according to the assigned cohort
Nucleus Network
Melbourne, Victoria, Australia
To evaluate the ability of cizutamig to reduce IgE levels
Change from baseline in serum IgE
Time frame: Baseline to Week 12
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Week 24
PK parameters: Cmax
Time frame: Baseline to 24 Weeks
PK parameters: Tmax
Time frame: Baseline to Week 24
PK parameters: AUC
Time frame: Baseline to 24 Weeks
PK Parameter: CL
Time frame: Baseline to 24 Weeks
PK Parameters: Vd
Time frame: Baseline to 24 Weeks
PK Parameters: t1/2
Time frame: Baseline to 24 Weeks
Anti-drug antibodies (ADAs)
Time frame: Baseline to 24 Weeks
Changes in body temperature
Time frame: Baseline to 24 Weeks
Changes to blood pressure
systolic and diastolic
Time frame: Baseline to 24 Weeks
Changes in heart rate
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Time frame: Baseline to 24 Weeks
Changes to respiratory rate
Time frame: Baseline to 24 Weeks
Changes to pulse oximetry
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QRS interval
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: PR interval
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QTcB
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QTcF
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QT interval
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: RR
Time frame: Baseline to 24 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to 24 Weeks
Changes from baseline in Red Blood Cell count
Time frame: Baseline to 24 Weeks
Changes from baseline in White Blood Cell count
Time frame: Baseline to 24 Weeks
Changes from baseline in Platelets
Time frame: Baseline to 24 Weeks
Changes from baseline in Hematocrit
Time frame: Baseline to 24 Weeks
Changes from baseline in Hemoglobin
Time frame: Baseline to 24 Weeks
Frequency and percentage of anti-drug antibodies (ADAs)
Time frame: Baseline to 24 Weeks