A Single Ascending Dose of HRS-2162 in Healthy Subjects

NCT07195604 | Recruiting Phase 1

• 1 other identifier: HRS-2162-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Reversal of Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  From ICF signing date to Day7

Secondary Outcomes (7)

• 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

Study Arms (7)

Dose Level：A1(Part1)

EXPERIMENTAL

Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1.

Drug: HRS-2162; Drug: Placebo

Dose Level：A2(Part1) .

EXPERIMENTAL

Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2.

Drug: HRS-2162; Drug: Placebo

Dose Level：B(Part1+Part2)

EXPERIMENTAL

Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B.

Drug: HRS-2162; Drug: Placebo

Dose Level：C(Part1)

EXPERIMENTAL

Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C.

Drug: HRS-2162; Drug: Placebo

Dose Level：D(Part1+Part3)

EXPERIMENTAL

Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D.

Drug: HRS-2162; Drug: Placebo

Dose Level：E(Part1)

EXPERIMENTAL

Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E.

Drug: HRS-2162; Drug: Placebo

Dose Level：F(Part3)

EXPERIMENTAL

Subject will receive HRS-2162 at dose level F

Drug: HRS-2162

Interventions

HRS-2162 DRUG

HRS-2162

Dose Level：A1(Part1); Dose Level：A2(Part1) .; Dose Level：B(Part1+Part2); Dose Level：C(Part1); Dose Level：D(Part1+Part3); Dose Level：E(Part1); Dose Level：F(Part3)

Placebo DRUG

Placebo

Dose Level：A1(Part1); Dose Level：A2(Part1) .; Dose Level：B(Part1+Part2); Dose Level：C(Part1); Dose Level：D(Part1+Part3); Dose Level：E(Part1)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Central Study Contacts

Yuanyuan Huang

CONTACT

0518-82342973; yuanyuan.huang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 26, 2025
• Study Start: September 25, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-09

Locations

CN (1)