The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).
This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe Eighth Affiliated Hospital of Southern Medical University (Shunde District People's Hospital of Foshan City)
Foshan, Guangdong, China
RECRUITINGGuangdong Provincial People's hospital
Guangzhou, Guangdong, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hubei, China
RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITING...and 4 more locations
Time frame: Baseline to Month 12
Pharmacokinetic (PK) parameters for Cizutamig: Cmax
Time frame: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Time frame: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Time frame: Baseline to Month 12
PK parameters for Cizutamig: clearance
Time frame: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Time frame: Baseline to Month 12
PK parameters for Cizutamig: half-life
Time frame: Baseline to Month 12