A Single Ascending Dose of HRS-2162 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Reversal of Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose Level：A1(Part1)

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

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Placebo

Intervention Type DRUG

Placebo

Dose Level：A2(Part1) .

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

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Placebo

Intervention Type DRUG

Placebo

Dose Level：B(Part1+Part2)

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

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Placebo

Intervention Type DRUG

Placebo

Dose Level：C(Part1)

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

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Placebo

Intervention Type DRUG

Placebo

Dose Level：D(Part1+Part3)

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

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Placebo

Intervention Type DRUG

Placebo

Dose Level：E(Part1)

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

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Placebo

Intervention Type DRUG

Placebo

Dose Level：F(Part3)

Subject will receive HRS-2162 at dose level F

Group Type EXPERIMENTAL

HRS-2162

Intervention Type DRUG

HRS-2162

Interventions

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HRS-2162

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes