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

InnoCare Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: ICP-332; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05399030

ICP-CL-00601

Details and patient eligibility

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

ICP-332

Experimental group

Description:

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

Treatment:

Drug: ICP-332

Placebo

Placebo Comparator group

Description:

Single ascending doses of placebo; Multiple ascending doses of placebo

Treatment:

Other: Placebo