| Eligibility |
Subject Inclusion Criteria (Must Meet All of the Following Criteria):
Inclusion Criteria:
1. Males or females with full capacity for civil conduct, aged = 18 and < 65 years old;
2. Weighing = 45 kg, and with a body mass index (BMI) of = 18 and = 28 kg/ m^2(BMI =
weight (kg)/height2 ( m^2));
3. For matched subjects with normal renal functions: physical examination, laboratory
tests (blood routine, blood biochemistry, urine routine, urinary albumin/creatinine
ratio, creatine kinase (CK) and coagulation function), and 12-lead ECG, etc. should be
normal or abnormal without clinical significance as determined by the investigator;
4. No potential difficult airway (modified Mallampati score of Grade I to II);
5. For matched subjects with normal renal functions: no history of major organ primary
diseases, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no
history of malignant hyperthermia and other genetic conditions; no history of
mental/neurological diseases; no history of epilepsy; no contraindications for deep
sedation/general anesthesia; no clinically significant history of anesthesia
accidents;
6. Subjects must understand the procedures and methods of this study, and be willing to
signing the informed consent form and to complete the trial in strict accordance with
clinical trial protocol;
Patients with Renal Impairment Must Also Meet the Following Criteria:
7. The estimated glomerular filtration rate (eGFR) of the subjects in corresponding
groups meets the criteria for mild to moderate renal impairment in the staging of
renal functions, i.e., mild renal impairment: 60-89 mL/min/1.73 m^2; moderate renal
impairment: 30-59 mL/min/1.73 m^2; subjects with normal renal functions: = 90
mL/min/1.73 m^2;
8. For subjects with renal impairment, their laboratory test results (coagulation
function, blood routine, urinary albumin/creatinine ratio, creatine kinase (CK), blood
biochemistry, and urine routine) should be judged by the investigators as clinically
stable and consistent with the severity of their renal impairment. In addition, their
albumin should be > 35 g/L and hemoglobin should be > 110 g/L;
Exclusion Criteria( those who meet any one of the followings are ineligible):
1. Known sensitivity to excipients in HSK3486 injectable emulsion (soybean oil, glycerin,
triglyceride, egg lecithin, sodium oleate and sodium hydroxide); history of drug
allergies (including other anesthetics);
2. Received any one of the following medications or treatments prior to
screening/enrollment:
History of drug abuse or any signs of long-term use of benzodiazepines (such as
insomnia, anxiety, spasms) within 3 months prior to screening; Participated in
clinical trials involving any medications or medical devices within 3 months prior to
screening, or subjects who have participated in 3 or more drug clinical trials within
the past year; Serious infection, trauma, or major surgery within 4 weeks before
screening; or acute disease with clinical significance (determined by the
investigators) within 2 weeks before screening, including GI diseases or infections
(such as respiratory tract or CNS infections); In receipt of propofol, other
sedatives/anesthetics and/or opioid analgesics or compounds containing analgesics
within 72 hrs prior to baseline; Used potent inhibitors of CYP enzyme within 7 days
prior to enrollment, or used moderate/low potency inhibitors of CYP enzyme within 3
days prior to enrollment;
3. History or evidence of any one of the following diseases prior to
screening/enrollment:
History of cardiovascular diseases such as: uncontrolled hypertension [SBP = 170 mmHg
and/or DBP = 105 without antihypertensive treatment, or SBP > 160 mmHg and/or DBP >
100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia,
heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6
months before screening, history of tachycardia/bradycardia requiring medication,
II-III degree atrioventricular block (excluding patients with pacemakers) or QTcF
interval = 450 ms (Fridericia's correction formula); Respiratory insufficiency,
history of obstructive pulmonary disease, history of asthma, sleep apnea; history of
failed tracheal intubation; history of bronchospasm requiring treatment within 3
months prior to screening; acute respiratory infection, and with obvious symptoms such
as fever, wheezing, nasal congestion or cough within 1 week prior to baseline; History
of gastrointestinal diseases: History of gastrointestinal retention, moderate and
above active bleeding (GUSTO bleeding classification), gastroesophageal reflux that
may lead to aspiration; [Note: GUSTO bleeding classification is: heavy or
life-threatening bleeding (intracranial hemorrhage or bleeding that causes hemodynamic
compromise and requires intervention), moderate bleeding (requires blood transfusion
but does not cause hemodynamic compromise), minor bleeding (does not meet the criteria
for either severe or moderate bleeding)]; History of cerebrovascular diseases: history
of craniocerebral injury, possible convulsions, intracranial hypertension, cerebral
aneurysm, or cerebrovascular accident; History of mental illness: schizophrenia,
mania, chronic use of antipsychotics, or cognitive impairment;
4. Positive test for either HBsAg, HCV, HIV, or syphilis;
5. History of alcohol abuse within 3 months prior to screening, alcohol abuse defined as
average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40%
alcohol or 150 mL wine), or positive alcohol breath test results at baseline;
6. Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3
months prior to screening;
7. Blood donation or blood loss = 200 mL within 30 days prior to screening; plasma
donation or plasma exchange within 7 days prior to screening;
8. Subjects who have consumed any beverages or foods containing alcohol, grapefruit juice
or methylxanthine (such as coffee, tea, cola, chocolate, and functional drinks),
participated in strenuous physical activities and other factors that may affect drug
absorption, distribution, metabolism, and excretion within 2 days prior to baseline;
subjects who are unable to fast for 8 hrs before dose administration;
9. Subjects expected to have surgery or hospitalization during the trial;
10. Subjects unsuitable for arterial blood collection, such as subjects who have positive
Allen's test results;
11. Other than the disease diagnosed as renal impairment, patients with acute illnesses in
any other organ, as well as those with chronic conditions that may affect the in vivo
process of the investigational drug (e.g., chronic hepatitis, hepatic insufficiency,
etc.);
12. Patients with autoimmune nephropathy, obstructive nephropathy, history of kidney
transplantation, and an ongoing dialysis treatment.
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