RecruitingPhase 1

A Single Ascending Dose of HRS-2162 in Healthy Subjects

China64 participantsStarted 2025-09-25

Plain-language 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

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The incidence and severity of adverse events

Timeframe: From ICF signing date to Day7

Trial details

NCT IDNCT07195604

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Yuanyuan Huang

0518-82342973 yuanyuan.huang@hengrui.com

View on ClinicalTrials.gov More Reversal of Neuromuscular Blockade trials