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CompletedNCT07195604Updated Sep 22, 2026

A Single Ascending Dose of HRS-2162 in Healthy Subjects

A Phase 1 interventional study of HRS-2162 and Placebo in Reversal of Neuromuscular Blockade, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • Reversal of Neuromuscular Blockade
03

In context

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Dose Level：A1(Part1)

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

    Drug: HRS-2162 · Drug: Placebo

  • Experimental
    Dose Level：A2(Part1) .

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

    Drug: HRS-2162 · Drug: Placebo

  • Experimental
    Dose Level：B(Part1+Part2)

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

    Drug: HRS-2162 · Drug: Placebo

  • Experimental
    Dose Level：C(Part1)

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

    Drug: HRS-2162 · Drug: Placebo

  • Experimental
    Dose Level：D(Part1+Part3)

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

    Drug: HRS-2162 · Drug: Placebo

  • Experimental
    Dose Level：E(Part1)

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

    Drug: HRS-2162 · Drug: Placebo

  • Experimental
    Dose Level：F(Part3)

    Subject will receive HRS-2162 at dose level F

    Drug: HRS-2162

Interventions

  • DrugHRS-2162

    HRS-2162

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: From ICF signing date to Day7

Secondary outcomes

  1. Maximum observed concentration of HRS-2162 (Cmax)

    Time frame: 0 hour to 24 hour after administration

  2. Area under the serum concentration time curve (AUC) of HRS-2162

    Time frame: 0 hour to 24 hour after administration

  3. Time to maximum observed concentration (Tmax) of HRS-2162

    Time frame: 0 hour to 24 hour after administration

  4. Half-life (T1/2) of HRS-2162

    Time frame: 0 hour to 24 hour after administration

  5. Clearance (CL) of HRS-2162

    Time frame: 0 hour to 24 hour after administration

  6. Volume of distribution (Vz) of HRS-2162

    Time frame: 0 hour to 24 hour after administration

  7. Efficacy endpoint: The time required from the administration of the investigational drug to the recovery of the TOFr value (T4/T1 value)

    Time frame: 0 hour to 1 hour after administration

07

Study locations

1 site
  • Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07195604
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Sep 25, 2025
Primary completion
Oct 9, 2025
Completion
Oct 9, 2025
Last update
Sep 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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