Single ascending single-dose HRS-2162 in healthy adults

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects

This will test a single dose of HRS-2162 versus placebo in healthy adults to see if it is safe, well tolerated, and how the drug is processed in the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07195604 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-ascending-dose, randomized placebo-controlled study in healthy adults designed to characterize safety, tolerability, and PK/PD of HRS-2162 after a single injection. Healthy volunteers meeting strict inclusion criteria (age 18–45, ASA I, specific weight and BMI ranges, and effective contraception) will receive ascending doses of HRS-2162 or placebo under close clinical monitoring. Safety labs, vital signs, and pharmacokinetic and pharmacodynamic measurements will be collected at planned timepoints following dosing. The study is conducted at a single site in Chengdu, China, and excludes individuals with significant medical history, bleeding or neuromuscular disorders, or prior anesthesia complications.

Who should consider this trial

Good fit: Ideal participants are healthy adults aged 18–45 with BMI 19–28 kg/m2, ASA class I, meeting the study's weight and contraception requirements and without significant medical history.

Not a fit: People with current or past acute or chronic illnesses, neuromuscular or bleeding disorders, abnormal screening labs, or previous anesthesia complications are excluded and would not benefit from participation.

Why it matters

Potential benefit: If successful, HRS-2162 could become a new option for reversing neuromuscular blockade, potentially improving speed or safety of recovery after anesthesia.

How similar studies have performed: Approved reversal agents such as sugammadex have demonstrated effective reversal of neuromuscular blockade, but HRS-2162 is a novel agent and human data are currently limited to early-phase testing.

Eligibility criteria

Inclusion Criteria:

1. The subjects voluntarily signed the informed consent form.
2. 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 .
3. ASA classification is Grade I (only Parts Two and three)
4. Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².
5. Adopt efficient contraceptive measures

Exclusion Criteria:

1. Those with a past or current clinical acute or chronic disease
2. Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .
3. Those with a history of neuromuscular diseases or poliomyelitis
4. Those with a history of anesthesia complications.
5. Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance
6. The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance
7. The subject has a history of severe systemic allergies for any reason.
8. 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.
9. History of drug abuse.
10. Those who the researchers considered unsuitable for inclusion

Where this trial is running

Chengdu, Sichuan

• Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Yuanyuan Huang

Conditions: Reversal of Neuromuscular Blockade