Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
SAD: Single subcutaneous administration, with a safe follow-up period of 60 days
MAD: Multiple administration, subcutaneous injection
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
SAD: The incidence rate of adverse events (AE)
Time frame: through study completion, an average of 60 days
SAD: The incidence rate of serious adverse events (SAE)
Time frame: through study completion, an average of 60 days
SAD: Number of subjects with clinically significant changes in physical examination results
Time frame: through study completion, an average of 60 days
SAD: Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate and blood pressure
Time frame: through study completion, an average of 60 days
SAD: Number of participants with abnormal laboratory tests results
laboratory tests including Blood routine、Blood Biochemistry (including blood lipids)、Coagulation routine、Urine routine、blood amylase、blood lipase、Pregnancy test、Calcitonin and Glycated hemoglobin (HbA1c)
Time frame: through study completion, an average of 60 days
SAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram
Time frame: through study completion, an average of 60 days
MAD: The incidence rate of adverse events (AE)
Time frame: through study completion, an average of 20 weeks
MAD: The incidence rate of serious adverse events (SAE)
Time frame: through study completion, an average of 20 weeks
MAD: Number of subjects with clinically significant changes in physical examination results
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Time frame: through study completion, an average of 20 weeks
MAD: Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate and blood pressure
Time frame: through study completion, an average of 20 weeks
MAD: Number of participants with abnormal laboratory tests results
laboratory tests including Blood routine、Blood Biochemistry (including blood lipids)、Coagulation routine、Urine routine、blood amylase、blood lipase、Pregnancy test、Calcitonin and Glycated hemoglobin (HbA1c)
Time frame: through study completion, an average of 20 weeks
MAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram
Time frame: through study completion, an average of 20 weeks
SAD: area under the curve (AUC)
Time frame: through study completion, an average of 60 days
SAD: maximum concentration (Cmax)
Time frame: through study completion, an average of 60 days
SAD: time to maximum concentration (Tmax)
Time frame: through study completion, an average of 60 days
SAD: clearance (CL/F)
Time frame: through study completion, an average of 60 days
SAD: apparent volume of distribution (V/F)
Time frame: through study completion, an average of 60 days
SAD: half-life (T1/2)
Time frame: through study completion, an average of 60 days
SAD: Anti-drug antibodies (ADA)
Time frame: through study completion, an average of 60 days
SAD: neutralizing antibodies (NAb)
Time frame: through study completion, an average of 60 days
MAD: area under the curve (AUC)
Time frame: through study completion, an average of 20 weeks
MAD: maximum concentration (Cmax)
Time frame: through study completion, an average of 20 weeks
MAD: time to maximum concentration (Tmax)
Time frame: through study completion, an average of 20 weeks
MAD: clearance (CL/F)
Time frame: through study completion, an average of 20 weeks
MAD: apparent volume of distribution (V/F)
Time frame: through study completion, an average of 20 weeks
MAD: half-life (T1/2)
Time frame: through study completion, an average of 20 weeks
MAD: Anti-drug antibodies (ADA)
Time frame: through study completion, an average of 20 weeks
MAD: neutralizing antibodies (NAb)
Time frame: through study completion, an average of 20 weeks
MAD: The change in body weight from baseline and the rate of change
Time frame: through study completion, an average of 20 weeks