Skip to content

Study on the safety, tolerability and dose-response relationship of HRS3797 administered by intravenous bolus in healthy adults

Study on the safety, tolerability and dose-response relationship of HRS3797 administered by intravenous bolus in healthy adults

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049149
Enrollment
Unknown
Registered
2021-07-23
Start date
2021-08-21
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle relaxant

Interventions

Experimental group1:Divided into two dose groups, 2 cases in each group, single dose
Experimental group2:Each volunteer gives 3 doses

Sponsors

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 45 years (including boundary value); 2. ASA classification is level I; 3. Male weight >=50 kg, female weight >=45 kg, body mass index (BMI) between 19.0 ~ 26.0 kg/m2 (including boundary values); 4. Volunteers have no sperm donation or egg donation plan within 3 months after signing the informed consent form, and voluntarily adopt efficient and reliable contraceptive methods to avoid pregnancy of female volunteers or pregnancy of male volunteer partners; 5. Volunteers have detailed knowledge of the nature, significance, possible benefits, possible inconvenience and potential risks and discomforts of the trial before the trial, can understand the procedures and methods of this research, and are willing to strictly comply with the requirements of the entire clinical research. And voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with past or current clinical acute and chronic diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, which may significantly affect the investigational drug as determined by the investigator Kinetic characteristics or safety assessors; 2. Those with a history of neuromuscular diseases (such as myotonic dystrophy, polio, myasthenia gravis, botulism) or poliomyelitis; 3. Those with a history of anesthesia complications; 4. Those with a history of asthma or airway diseases requiring treatment; 5. Those who have a history of anatomical airway abnormalities, or have signs of airway abnormalities assessed during screening airway examinations, which may affect laryngoscope placement or tracheal intubation; 6. Those with a history or family history of malignant hyperthermia, or those susceptible to malignant hyperthermia (patients with congenital diseases such as idiopathic scoliosis, strabismus, ptosis, umbilical hernia, inguinal hernia, etc.); 7. Those who have any history of allergies in the past, or those who have specific allergic diseases (such as allergic asthma, urticaria, eczema, etc.); 8. Those who have undergone major surgery within 3 months (90 days) before screening; 9. Those who have undergone surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or those who plan to undergo surgery during the study period; 10. Those who have received antihistamines or antidepressants within 3 months (90 days) before screening; 11. Use of any drugs that inhibit or induce liver metabolism of drugs within 30 days before administration (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRIs) Antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 12. Those who have been vaccinated within 30 days before administration; 13. Those who have used any drugs or health products (including Chinese herbal medicine) within 14 days before administration; 14. During the screening period, it is known that other drug treatment may be required during the research period; 15. Those who have used any clinical research drug within 3 months (90 days) before screening, or plan to participate in other clinical trials during this study; 16. Those who donated blood/blood loss >=400 mL within 3 months (90 days) before screening (except for female physiological blood loss), received blood transfusion or used blood products, or planned to donate blood during the trial or within 1 month after the trial; 17. Those who smoked more than 5 cigarettes on average per day within 3 months (90 days) before screening, or who could not quit smoking during the trial; 18. Frequent drinkers (over 14 units of alcohol per week on average, 1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within 3 months (90 days) prior to screening, or trial Those who cannot stop drinking during the period; 19. Those who drank too much tea, coffee or caffeinated beverages (over 8 cups per day on average, 1 cup = 200 mL) within 3 months (90 days) before screening; 20. Those who consume special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine-containing food or drink) within

Design outcomes

Primary

MeasureTime frame
plasma concentration;

Countries

China

Contacts

Public ContactYang Guoping

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

ygp9880@126.com+86 731 89918665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026