Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Adults
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a single dose of HRS-2162 injection in healthy adults aged 18 to 45 years. This Phase 1 study also aims to understand the drug's pharmacokinetics (PK) and pharmacodynamics (PD) characteristics. The study is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. and focuses on the reversal of neuromuscular blockade. Participants are randomly assigned to receive one of several dose levels of HRS-2162 or a matching placebo. The study uses a quadruple masking design, meaning participants, care providers, investigators, and outcomes assessors are unaware of the assigned treatments. Dose levels range from A1 to F, with some parts including placebo controls and others including only HRS-2162. During the study, participants are monitored for adverse events from the time they consent until seven days after dosing. Blood samples are collected up to 24 hours after administration to measure drug concentration and other PK parameters like maximum concentration, area under the curve, half-life, clearance, and volume of distribution. Researchers also assess the time for recovery of a specific neuromuscular function (TOFr value) within one hour after dosing. The total participation duration varies by dose level and study part.
CONDITIONS
Brief Title
A Single Ascending Dose of HRS-2162 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily signed the informed consent form
- Age between 18 and 45 years at consent
- Includes both men and women
- ASA classification Grade I (only for Parts Two and Three)
- Male weight at least 50 kg, female weight at least 45 kg
- Body mass index between 19 and 28 kg/m²
- Use of effective contraceptive measures
You will not qualify if you...
- History or current presence of acute or chronic diseases
- History of hereditary bleeding or coagulation disorders or unexplained bleeding
- History of neuromuscular diseases or poliomyelitis
- History of anesthesia complications
- Abnormal laboratory test results with clinical significance at screening or baseline
- Abnormal blood pressure judged clinically significant
- History of severe systemic allergies
- Use of steroid hormone drugs within 7 half-lives or 14 days before administration
- Smoking more than 5 cigarettes per day within 3 months prior to the study
- History of drug abuse
- Any condition deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of the investigational drug or placebo and are monitored for safety and pharmacokinetics.
1 dosing visit and multiple assessments within 24 hours
Duration - 7 days
Participants are monitored for adverse events and safety for up to 7 days after dosing.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
Research Team
Y
Yuanyuan Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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