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NCT Number: NCT07195604

A Single Ascending Dose of HRS-2162 in Healthy Subjects

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Chengdu, Sichuan, 610072, China

Location status: Recruiting

Location contact

Mengchang Yang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Those who the researchers considered unsuitable for inclusion

Treatment and study plan

HRS-2162

Drug

HRS-2162

Placebo

Drug

Placebo

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanyuan Huang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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