Reversal of Neuromuscular Blockade
Conditions
Brief summary
The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
Interventions
DRUGHRS-2162
HRS-2162
DRUGPlacebo
Placebo
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subjects voluntarily signed the informed consent form. 2. Applicants must be between 18 and 45 years old at the time of signing the informed consent form, and both men and women are eligible . 3. ASA classification is Grade I (only Parts Two and three) 4. Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ². 5. Adopt efficient contraceptive measures
Exclusion criteria
1. Those with a past or current clinical acute or chronic disease 2. Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding . 3. Those with a history of neuromuscular diseases or poliomyelitis 4. Those with a history of anesthesia complications. 5. Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance 6. The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance 7. The subject has a history of severe systemic allergies for any reason. 8. The subjects took steroid hormone drugs within 7 half-lives or 14 days before administrationSmoke ≥5 cigarettes per day within 3 months prior to the study. 9. History of drug abuse. 10. Those who the researchers considered unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | From ICF signing date to Day7 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum concentration time curve (AUC) of HRS-2162 | 0 hour to 24 hour after administration |
| Time to maximum observed concentration (Tmax) of HRS-2162 | 0 hour to 24 hour after administration |
| Half-life (T1/2) of HRS-2162 | 0 hour to 24 hour after administration |
| Maximum observed concentration of HRS-2162 (Cmax) | 0 hour to 24 hour after administration |
| Volume of distribution (Vz) of HRS-2162 | 0 hour to 24 hour after administration |
| Efficacy endpoint: The time required from the administration of the investigational drug to the recovery of the TOFr value (T4/T1 value) | 0 hour to 1 hour after administration |
| Clearance (CL) of HRS-2162 | 0 hour to 24 hour after administration |
Countries
China
Contacts
Primary ContactYuanyuan Huang
Outcome results
None listed