Recruiting NCT07195604
A Single Ascending Dose of HRS-2162 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-2162, Placebo.
- Who it may be relevant to
- Registry conditions: Reversal of Neuromuscular Blockade. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects
Overview
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
- Drug HRS-2162
HRS-2162 - Drug Placebo
Placebo
Primary outcome measures
- The incidence and severity of adverse events [Time frame: From ICF signing date to Day7]
Secondary outcome measures (7)
- Maximum observed concentration of HRS-2162 (Cmax) [Time frame: 0 hour to 24 hour after administration]
- Area under the serum concentration time curve (AUC) of HRS-2162 [Time frame: 0 hour to 24 hour after administration]
- Time to maximum observed concentration (Tmax) of HRS-2162 [Time frame: 0 hour to 24 hour after administration]
- Half-life (T1/2) of HRS-2162 [Time frame: 0 hour to 24 hour after administration]
- Clearance (CL) of HRS-2162 [Time frame: 0 hour to 24 hour after administration]
- Volume of distribution (Vz) of HRS-2162 [Time frame: 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) [Time frame: 0 hour to 1 hour after administration]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital — Chengdu
Identifiers
NCT: NCT07195604 · HRS-2162-101