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

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

Study Overview

• Status: Recruiting
• Conditions: Reversal of Neuromuscular Blockade
• Intervention / Treatment: Drug: Placebo; Drug: HRS-2162

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuanyuan Huang; Phone Number: 0518-82342973; Email: yuanyuan.huang@hengrui.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
      • Principal Investigator: Mengchang Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level：A1(Part1); Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1.	Drug: Placebo; Placebo; Drug: HRS-2162; HRS-2162
Experimental: Dose Level：A2(Part1) .; Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2.	Drug: Placebo; Placebo; Drug: HRS-2162; HRS-2162
Experimental: Dose Level：B(Part1+Part2); Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B.	Drug: Placebo; Placebo; Drug: HRS-2162; HRS-2162
Experimental: Dose Level：C(Part1); Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C.	Drug: Placebo; Placebo; Drug: HRS-2162; HRS-2162
Experimental: Dose Level：D(Part1+Part3); Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D.	Drug: Placebo; Placebo; Drug: HRS-2162; HRS-2162
Experimental: Dose Level：E(Part1); Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E.	Drug: Placebo; Placebo; Drug: HRS-2162; HRS-2162
Experimental: Dose Level：F(Part3); Subject will receive HRS-2162 at dose level F	Drug: HRS-2162; HRS-2162

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence and severity of adverse events	From ICF signing date to Day7

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration of HRS-2162 (Cmax)	0 hour to 24 hour after administration
Area under the serum concentration time curve (AUC) of HRS-2162	0 hour to 24 hour after administration
Time to maximum observed concentration (Tmax) of HRS-2162	0 hour to 24 hour after administration
Half-life (T1/2) of HRS-2162	0 hour to 24 hour after administration
Clearance (CL) of HRS-2162	0 hour to 24 hour after administration
Volume of distribution (Vz) of HRS-2162	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)	0 hour to 1 hour after administration

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 14, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Estimated): September 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HRS-2162-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No