A Single Ascending Dose of HRS-2162 in Healthy Subjects

Not Applicable

Not yet recruiting

• Conditions: Reversal of Neuromuscular Blockade
• Interventions: Drug: HRS-2162; Drug: Placebo

• Registration Number: NCT07195604
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-14
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Level：A1(Part1)	HRS-2162	Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1.
Dose Level：A1(Part1)	Placebo	Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1.
Dose Level：A2(Part1) .	HRS-2162	Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2.
Dose Level：A2(Part1) .	Placebo	Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2.
Dose Level：E(Part1)	Placebo	Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E.
Dose Level：B(Part1+Part2)	HRS-2162	Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B.
Dose Level：B(Part1+Part2)	Placebo	Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B.
Dose Level：C(Part1)	Placebo	Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C.
Dose Level：C(Part1)	HRS-2162	Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C.
Dose Level：D(Part1+Part3)	HRS-2162	Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D.
Dose Level：D(Part1+Part3)	Placebo	Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D.
Dose Level：E(Part1)	HRS-2162	Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E.
Dose Level：F(Part3)	HRS-2162	Subject will receive HRS-2162 at dose level F

Primary Outcome Measures

Name	Time	Method
The incidence and severity of adverse events	From ICF signing date to Day7

Secondary Outcome Measures

Name	Time	Method
Maximum observed concentration of HRS-2162 (Cmax)	0 hour to 24 hour after administration
Half-life (T1/2) 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
Area under the serum concentration time curve (AUC) 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
Time to maximum observed concentration (Tmax) of HRS-2162	0 hour to 24 hour after administration

Trial Locations

Locations (1)

Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China