A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects
NCT ID: NCT05399030
Last Updated: 2022-08-08
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
72 participants
INTERVENTIONAL
2021-08-14
2022-02-18
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
OTHER
TRIPLE
Study Groups
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ICP-332
Single ascending doses of ICP-332 tablet; Multiple ascending doses of ICP-332 tablet
ICP-332
ICP-332 will be administered as tablet
Placebo
Single ascending doses of placebo; Multiple ascending doses of placebo
Placebo
Matching placebo will be administered as tablet
Interventions
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ICP-332
ICP-332 will be administered as tablet
Placebo
Matching placebo will be administered as tablet
Eligibility Criteria
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Inclusion Criteria
2. Age and fertility status
1. Male or infertile female subjects who are between 18-45 years old (inclusive).
2. Female subjects who are infertile.
3. Male subjects and their partners must agree to use effective contraception.
Exclusion Criteria
2. Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption.
3. Acute disease state (such as nausea, vomiting, pyrexia or diarrhea, etc.) within 14 days before administration.
4. Other situations judged by the investigator to be unsuitable to join this trial.
18 Years
45 Years
ALL
Yes
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Qing Wen
Role: PRINCIPAL_INVESTIGATOR
Jinan Central Hospital
Locations
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Jinan Central Hospital
Jinan, , China
Countries
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Other Identifiers
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ICP-CL-00601
Identifier Type: -
Identifier Source: org_study_id
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