RecruitingPhase 1NCT07195604
A Single Ascending Dose of HRS-2162 in Healthy Subjects
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Enrollment
64 participants
Start Date
Sep 25, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 45 Years
Inclusion Criteria5
- 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 Criteria10
- 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
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Interventions
DRUGHRS-2162
HRS-2162
DRUGPlacebo
Placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07195604