Pain
Conditions
Interventions
Group 1:0.025 mg/kg :On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting
the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.
Group 1:0.05 mg/kg(including 2 placebo cases and 2 positive controls):On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting
Group 1:0.1 mg/kg(including 2 placebo cases and 2 positive controls):On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting
the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.The pos
Group 1:0.2 mg/kg(including 2 placebo cases and 2 positive controls):On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting
Group 1:0.3 mg/kg(including 2 placebo cases and 2 positive controls):On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting
the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under f
Sponsors
Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult men and women of full civil capacity, aged > = 18 and = 19 and = 90 and = 60mmHg and = 60 and = 35.4 and = 10 and = 95% when sucking air. 4. Physical examination, laboratory tests (blood routine, blood biochemistry, blood transfusion, coagulation function and urine routine), 12-lead electrocardiogram, abdominal B ultrasound, and chest X-ray were normal or abnormal but not clinically significant as judged by the investigator. 5. Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the clinical trial protocol to complete the trial.
Exclusion criteria
Exclusion criteria: 1. Individuals with a known allergy to eggs, soy products, excipients in Propoon Injection, HYH2006078P1 for Injection, or excipients (sulfobutylether ß-cyclodextrin sodium, acid, sodium citrate); individuals with a history of drug allergy (including anesthetic drugs), allergic diseases, or a constitution prone to allergies. 2. Individuals with a history of difficultntilation or suspected difficult airway, or those predicted to have difficulty with tracheal intubation (e.g., Modified Mallampati score III-IV, micrmia with macroglossia, mandibular hypoplasia, etc.). 3. Individuals who received inactivated vaccination within 1 month prior to screening, or received ctivated/attenuated vaccination within 3 months prior to screening, or plan to receive inactivated/attenuated vaccination during the trial. 4. Individuals with contraindicat to deep sedation/general anesthesia, or a history of adverse events during sedation/anesthesia. 5. Individuals who used any of the following drugs or treatments prior to screening/erollment: 1) History of drug abuse within 3 months prior to the screening period, long-term use of psychotropic drugs, or any signs of long-term use of benzoiazepines (e.g., insomnia, anxiety, spasms), or positive results in urine drug screening (during the screening period or baseline period); 2) Participated in any clinical tr of drugs or medical devices within 3 months prior to screening; 3) Used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, or food supplements (e.gins, calcium supplements) other than oral contraceptives, acetaminophen, oral non-steroidal anti-inflammatory drugs, and topical over-the-counter preparations within 2 weeks prior t enrollment; unless the Principal Investigator (PI) and the Sponsor jointly determine that the medication used has no impact on the safety and PK/PD results of this trial, enrollment s allowed. 6. Individuals with a history of severe trauma or major surgery within 4 weeks prior to screening. 7. Individuals with a history or evidence of any of the following diseases prior o screening: 1) History of cardiovascular diseases such as: hypertension, severe arrhythmia, heart failure, ischemic heart disease, Adams-Stokes syndrome, tacardia or bradycardia requiring medication, or male QTcF interval >=450ms/female QTcF interval >=460ms (corrected bFridericia's formula); 2) History of respiratory diseases: respiratory insufficiency, sleep apnea syndrome, history of obstructive lung disease, asthma, or history of sm requiring treatment within 3 months prior to screening, or acute respiratory infection with obvious symptoms within 1 week prior to baseline; 3) History of cerebrovascular diseases:head injury, possible seizures, myoclonus, intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident; history of schizophrenia, ia, delirium, cognitive dysfunction, etc.; or acute intracranial infection with obvious symptoms within 1 week prior to baseline; 4) History of gastrointestinal diseases: gastrointestinal retenive bleeding, or conditions that may lead to reflux aspiration; or acute gastrointestinal infection with obvious symptoms within 1 week prior to baseline; 5) Uncontrolled diseases with significant clinical sicance, such as liver, kidney, hematological, neurological, or metabolic diseases, which the investigator judges may make the individual unsuitable for participation in the study. 8. Individualwho smoked =5 cigarettes per day within 3 months pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead electrocardiogram indicators;Vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Indicators;Eyelash reflex;Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score;Bispectral Index;Time to recovery of orientation ;Modified Aldrete score; | — |
Countries
China
Contacts
Public ContactYang Guoping
Xiangya Third Hospital of Central South University
Outcome results
None listed