A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects

Study Overview
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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

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: ICP-332
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Age and fertility status Male or infertile female subjects who are between 18-45 years old (inclusive). Female subjects who are infertile. Male subjects and their partners must agree to use effective contraception. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic and other diseases, or allergic diseases. Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption. Acute disease state (such as nausea, vomiting, pyrexia or diarrhea, etc.) within 14 days before administration. Other situations judged by the investigator to be unsuitable to join this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-332<br>Single ascending doses of ICP-332 tablet; Multiple ascending doses of ICP-332 tablet | Drug: ICP-332<br>* ICP-332 will be administered as tablet<br>|
| Placebo Comparator: Placebo<br>Single ascending doses of placebo; Multiple ascending doses of placebo | Other: Placebo<br>* Matching placebo will be administered as tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Treatment-Emergent Adverse Events (AEs). |  | Baseline up to 28 days after last dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Maximum concentration (Cmax) |  | Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14. | 
| Change from baseline in blood cells. | measuraments (e.g. blood biochemistry tests, hematology, coagulation tests); outcome measure (e.g. absolute blood cells count) | Multiple ascending dose: Baseline to 28 days. |