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Completed

NCT Number: NCT07123376

Pharmacokinetics, Pharmacodynamics Profile and Tolerance of HRS-9231 in Healthy Subjects

To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 to 45 years.
  • Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
  • Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion criteria

  • Patients with contraindications for magnetic resonance imaging (MRI) examinations.
  • During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
  • Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
  • Unable to tolerate venipunctures or have a history of fainting needles and blood.
  • People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)

Treatment and study plan

HRS-9231

Drug

HRS-9231 was administered intravenously;

Placebo

Drug

Placebo was administered intravenously.

Primary outcomes

  1. Adverse events, serious adverse events

    Time frame: From ICF signing date to Day10

Secondary outcomes

  1. Cmax：maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration

    Time frame: From baseline (1 hour before injection) to 12 hours post-injection

  2. t1/2 = terminal elimination half-life of the compound

    Time frame: From baseline (1 hour before injection) to 12 hours post-injection

  3. Cl = total clearance

    Time frame: From baseline (1 hour before injection) to 12 hours post-injection

Sponsors and collaborators

Lead sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HRS-9231 Injection in a Single Dose in Healthy Chinese Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2025
Registry last updated
Aug 14, 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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