Phase I Study of ICP-332 in Healthy Subjects

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-23

Study Completion Date

2024-12-25

Brief Summary

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A multiple ascending dose phase I study of ICP-332 in healthy subjects

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ICP-332

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

Eligible patients will receive ICP-332 tablets orally as per the protocol

Placebo

Group Type PLACEBO_COMPARATOR

ICP-332 Placebo Tablets

Intervention Type DRUG

Eligible patients will receive ICP-332 placebo tablets orally as per the protocol

Interventions

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ICP-332 Tablets

Eligible patients will receive ICP-332 tablets orally as per the protocol

Intervention Type DRUG

ICP-332 Placebo Tablets

Eligible patients will receive ICP-332 placebo tablets orally as per the protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily sign the informed consent form
2. Body mass index (BMI) of ≥ 18.5 kg/m2 and \< 30 kg/m2
3. Male or infertile female subjects who are between 18-55 years old (inclusive)

Exclusion Criteria

1. Significant current or past acute or chronic disease or condition.
2. A history of tuberculosis or current active/latent infection.
3. With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
4. Subjects with clinically significant abnormalities in the screening examinations.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes