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

NCT07123376 | Completed Phase 1

• 1 other identifier: HRS-9231-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Adverse events, serious adverse events

  From ICF signing date to Day10

Secondary Outcomes (3)

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

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

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

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

• Cl = total clearance

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

Study Arms (5)

Group 1

EXPERIMENTAL

8 healthy subjects were to be included

Drug: HRS-9231; Drug: Placebo

Group 2

EXPERIMENTAL

8 healthy subjects were to be included

Drug: HRS-9231; Drug: Placebo

Group 3

EXPERIMENTAL

8 healthy subjects were to be included

Drug: HRS-9231; Drug: Placebo

Group 4

EXPERIMENTAL

8 healthy subjects were to be included

Drug: HRS-9231; Drug: Placebo

Group 5

EXPERIMENTAL

8 healthy subjects were to be included

Drug: HRS-9231; Drug: Placebo

Interventions

HRS-9231 DRUG

HRS-9231 was administered intravenously;

Group 1; Group 2; Group 3; Group 4; Group 5

Placebo DRUG

Placebo was administered intravenously.

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Shanghai Shengdi Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: June 5, 2024
• Primary Completion: October 6, 2024
• Study Completion: October 6, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

CN (1)