Pharmacokinetics, Pharmacodynamics Profile and Tolerance of HRS-9231 in Healthy Subjects
NCT ID: NCT07123376
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2024-06-05
2024-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
TRIPLE
Study Groups
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Group 1
8 healthy subjects were to be included
HRS-9231
HRS-9231 was administered intravenously;
Placebo
Placebo was administered intravenously.
Group 2
8 healthy subjects were to be included
HRS-9231
HRS-9231 was administered intravenously;
Placebo
Placebo was administered intravenously.
Group 3
8 healthy subjects were to be included
HRS-9231
HRS-9231 was administered intravenously;
Placebo
Placebo was administered intravenously.
Group 4
8 healthy subjects were to be included
HRS-9231
HRS-9231 was administered intravenously;
Placebo
Placebo was administered intravenously.
Group 5
8 healthy subjects were to be included
HRS-9231
HRS-9231 was administered intravenously;
Placebo
Placebo was administered intravenously.
Interventions
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HRS-9231
HRS-9231 was administered intravenously;
Placebo
Placebo was administered intravenously.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Exclusion Criteria
2. During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
3. Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
4. Unable to tolerate venipunctures or have a history of fainting needles and blood.
5. People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)
18 Years
45 Years
ALL
Yes
Sponsors
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Shanghai Shengdi Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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HRS-9231-101
Identifier Type: -
Identifier Source: org_study_id
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