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Healthy Subjects

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

Sponsored by Beijing InnoCare Pharma Tech Co., Ltd.

About this trial

Last updated 3 years ago

Study ID

ICP-CL-00601

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 45 Years
All
All

Trial Timing

Ended 3 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.
No

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.

Locations

Location

Status