Actively Recruiting

Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07195604

A Single Ascending Dose of HRS-2162 in Healthy Subjects

Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17

64

Participants Needed

1

Research Sites

9 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

A Single Ascending Dose of HRS-2162 in Healthy Subjects

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must voluntarily sign the informed consent form
  • Age between 18 and 45 years at the time of consent
  • Both men and women are eligible
  • ASA classification must be Grade I
  • Male weight at least 50 kg, female weight at least 45 kg
  • Body mass index between 19 and 28 kg/m²
  • Use effective contraceptive measures
Not Eligible

You will not qualify if you...

  • Past or current acute or chronic clinical diseases
  • History of hereditary bleeding or coagulation disorders or non-traumatic bleeding
  • History of neuromuscular diseases or poliomyelitis
  • History of anesthesia complications
  • Laboratory test results outside normal range with clinical significance
  • Abnormal blood pressure considered clinically significant
  • History of severe systemic allergies
  • Use of steroid hormone drugs within 7 half-lives or 14 days before administration
  • Smoking 5 or more cigarettes per day within 3 months before the study
  • History of drug abuse
  • Considered unsuitable for inclusion by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Chengdu, Sichuan, China, 610072

Actively Recruiting

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Research Team

Y

Yuanyuan Huang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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A Single Ascending Dose of HRS-2162 in Healthy Subjects | DecenTrialz