This trial is conducted in china. The aim of the trial is as follows: * To assess the effect of multiple subcutaneous injections of JY09 injection on the pharmacokinetic (PK) profile of multiple oral doses of metformin hydrochloride tablets, a single oral dose of Rosuvastatin calcium tablets, or digoxin tablets in overweight Chinese subjects; * To assess the effect of multiple subcutaneous injections of JY09 injection on QT interval in overweight Chinese subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
D22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29, D36, D43, D50, D57, D64, D71, and D78 subjects returned to the study center to receive a subcutaneous abdominal injection of 2.4 mg of JY09 injection(total of 8 administrations).All doses were to be administered within 3 min.
D1 to D4 continuous oral administration of 0.5 g metformin hydrochloride tablets twice daily (D4 was administered only in the morning, with a total of 7 administrations) for a washout period of 96 h;0.5 g metformin hydrochloride tablets orally twice a day continuously from D85 to D88 (D88 was given only in the morning, for a total of 7 doses).
D8 received a single oral administration of 10 mg of Rosuvastatin calcium tablets in the morning, with a washout period of 168 h,and 10 mg Rosuvastatin calcium tablets orally at 72 h ± 0.5 h (D95) after JY09 administration.
D15 received a single oral administration of 0.25 mg digoxin tablets in the morning, with a washout period of 168 h,oral 0.25 mg digoxin tablets 72 h±0.5 h after JY09 administration (D102)
Peking University Third Hospital drug clinical trial Institute
Beijing, Beijing Municipality, China
The Metformin Peak Concentration (Cmax )
The peak concentration(Cmax) is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Time frame: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
Area under the Metformin blood concentration-time curve
AUC refers to the area under the drug time curve, which is the area surrounded by the pharmacokinetic blood concentration curve to the time axis. This parameter is an important index to evaluate the degree of drug absorption, reflecting the exposure characteristics of drugs in vivo.
Time frame: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
The Rosuvastatin Peak Concentration (Cmax )
The peak concentration(Cmax) is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Time frame: From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
Area under the Rosuvastatin blood concentration-time curve
Area under curve(AUC) refers to the area under the drug time curve, which is the area surrounded by the pharmacokinetic blood concentration curve to the time axis. This parameter is an important index to evaluate the degree of drug absorption, reflecting the exposure characteristics of drugs in vivo.
Time frame: From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
The Digoxin Peak Concentration (Cmax )
The peak concentration(Cmax) is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Time frame: From time 0 to 168 hours after a single dose of Digoxin without JY09 exposure (Day 15) and at JY09 steady state (Day 102)
Baseline-corrected difference of Corrected QT interval after multiple subcutaneous injections of JY09 injection
Corrected QT interval is a QT interval adjusted by heart rate, which is an index of cardiac depolarization and repolarization
Time frame: From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92)
Safety endpoint-Adverse events
All adverse medical events occurring after the subject receives the experimental drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily have a causal relationship with the experimental drug.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Blood pressure
Blood pressure includes systolic and diastolic blood pressure.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Pulse
Pulse refers to the pulsation formed in the arteries when the heart contracts, due to the flow of blood from the heart into the arteries. Pulse is one of the vital signs of human body, and it is an important index to measure heart rate and blood pressure.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Respiration
Respiration refers to the process of gas exchange between the body and the outside world.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Physical examination
Include general condition, skin, neck (including thyroid), head (including eyes, ears, nose, throat), chest, abdomen, back, lymph nodes, limbs, and nervous system.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Routine blood
Blood routine refers to the examination of blood conditions and diseases by observing the changes in the number and morphological distribution of blood cells.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Blood biochemistry
Blood biochemical examination can determine the content of sugars, lipids, hormones, ions and other substances in the blood, and provide help for the diagnosis and treatment of diseases.
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Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Urine routine
Urine routine is of great significance not only for the observation of the curative effect of the diagnosis of urinary system diseases, but also for the diagnosis and prognosis of other system diseases.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-coagulation function
The coagulation function test is mainly to find out whether the clotting factors in the patient's body are abnormal.
Time frame: From baseline (Day -1) to follow-up (Day 123)
12-lead electrocardiogram (ECG)
Electrocardiogram (ECG) is an objective index of the occurrence, propagation and recovery of cardiac excitation. It is used for the examination of various arrhythmias, ventricular and atrial hypertrophy, myocardial infarction, arrhythmia, myocardial ischemia and other diseases.
Time frame: From baseline (Day -1) to follow-up (Day 123)
Immunogenicity
Immunogenicity refers to the performance that can cause an immune response, that is, the antigen can stimulate specific immune cells, so that immune cells activation, proliferation, differentiation, and eventually produce immune effecting substances antibodies and sensitized lymphocytes.
Time frame: From baseline (Day -1) to follow-up (Day 123)