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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Placebo; Drug: ICP-332

• Registration Number: NCT05399030
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-08-14
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-18
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single ascending doses of placebo; Multiple ascending doses of placebo
ICP-332	ICP-332	Single ascending doses of ICP-332 tablet; Multiple ascending doses of ICP-332 tablet

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment-Emergent Adverse Events (AEs).	Baseline up to 28 days after last dose.

Secondary Outcome Measures

Name	Time	Method
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.	Multiple ascending dose: Baseline to 28 days.	measuraments (e.g. blood biochemistry tests, hematology, coagulation tests); outcome measure (e.g. absolute blood cells count)

Trial Locations

Locations (1)

Jinan Central Hospital; 🇨🇳 Jinan, China