Status:
RECRUITING
A Single Ascending Dose of HRS-2162 in Healthy Subjects
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions:
Reversal of Neuromuscular Blockade
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- The subjects voluntarily signed the informed consent form.
- 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 .
- ASA classification is Grade I (only Parts Two and three)
- Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².
- Adopt efficient contraceptive measures
Exclusion
- Those with a past or current clinical acute or chronic disease
- Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .
- Those with a history of neuromuscular diseases or poliomyelitis
- Those with a history of anesthesia complications.
- Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance
- The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance
- The subject has a history of severe systemic allergies for any reason.
- 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.
- History of drug abuse.
- Those who the researchers considered unsuitable for inclusion
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07195604
Start Date
September 25 2025
End Date
December 1 2025
Last Update
November 17 2025
Active Locations (1)
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1
Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072