Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
81
Subcutaneous injection in the abdominal area
Subcutaneous injection in the abdominal area
Subcutaneous injection in the abdominal area
No. 9, Shuangxing Avenue,, Bishan
Chongqing, Bishan, China
RECRUITINGNo. 9, Shuangxing Avenue,
Bishan, Chongqing Municipality, China
NOT_YET_RECRUITINGAdverse event
Frequency, type and severity of adverse events/serious adverse events.
Time frame: From Day1 to Day36
Electrocardiogram parameter(Heart rate)
Evaluation the heart rate of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Electrocardiogram parameter(PR interval)
Evaluation the PR interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Electrocardiogram parameter(QTcF interval)
Evaluation the QTcF interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Electrocardiogram parameter(QRS interval)
Evaluation the QRS interval of electrocardiogram parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Vital signs parameter(Body temperature)
Evaluation the body temperature of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Vital signs parameter(Blood pressure)
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Evaluation the blood pressure of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Vital signs parameter(Pulse)
Evaluation the pulse of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Vital signs parameter(Respiration)
Evaluation the respiration of vital signs parameters, and summarize the baseline data, post-administration data, and the changes from baseline after administration for each visit and treatment group.
Time frame: From Day1 to Day36
Cmax
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
AUC0-t
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
Tmax
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
T1/2
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
CL/F
Evaluate the pharmacokinetic effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
GIRmax
Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
tGIRmax
Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
AUCGIR
Evaluate the Pharmacodynamics effects of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36
ADA(Anti-Drug Antibody)
Evaluate the Immunogenic characteristics of HEC-151 Injection in healthy participants.
Time frame: From Day1 to Day36