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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-14

Study Completion Date

2022-02-18

Brief Summary

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This is a randomized, double-blind, placebo-controlled, parallel group, single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-332 in Healthy Subjects

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ICP-332

Single ascending doses of ICP-332 tablet; Multiple ascending doses of ICP-332 tablet

Group Type EXPERIMENTAL

ICP-332

Intervention Type DRUG

ICP-332 will be administered as tablet

Placebo

Single ascending doses of placebo; Multiple ascending doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo will be administered as tablet

Interventions

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ICP-332

ICP-332 will be administered as tablet

Intervention Type DRUG

Placebo

Matching placebo will be administered as tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Body mass index (BMI) between 18-26 kg/m2, the weight of male subject should not be less than 50 kg, and the weight of female subject should not be less than 45 kg.
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

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic and other diseases, or allergic diseases.
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qing Wen

Role: PRINCIPAL_INVESTIGATOR

Jinan Central Hospital

Locations

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Jinan Central Hospital

Jinan, , China

Site Status

Countries

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China

Other Identifiers

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ICP-CL-00601

Identifier Type: -

Identifier Source: org_study_id

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