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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399030
• Other study ID #: ICP-CL-00601
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: August 2022
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 18, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ICP-332
ICP-332 will be administered as tablet

Other:
• Placebo
Matching placebo will be administered as tablet

Locations

Country	Name	City	State
China	Jinan Central Hospital	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment-Emergent Adverse Events (AEs).		Baseline up to 28 days after last dose.
Secondary	Change from baseline in Maximum concentration (Cmax)		Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14.
Secondary	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.