A Single Ascending Dose of HRS-2162 in Healthy Subjects

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Reversal of Neuromuscular Blockade

Treatments: Drug: HRS-2162; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07195604

HRS-2162-101

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 7 patient groups

Dose Level：A1(Part1)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-2162

Dose Level：A2(Part1) .

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-2162

Dose Level：B(Part1+Part2)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-2162

Dose Level：C(Part1)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-2162

Dose Level：D(Part1+Part3)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-2162

Dose Level：E(Part1)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-2162

Dose Level：F(Part3)

Experimental group

Description:

Subject will receive HRS-2162 at dose level F

Treatment:

Drug: HRS-2162