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

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05399030

Collaborator

(none)

Enrollment

Location

Arms

6.2

Actual Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: ICP-332 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Aug 14, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Feb 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICP-332 Single ascending doses of ICP-332 tablet; Multiple ascending doses of ICP-332 tablet	Drug: ICP-332 ICP-332 will be administered as tablet
Placebo Comparator: Placebo Single ascending doses of placebo; Multiple ascending doses of placebo	Other: Placebo Matching placebo will be administered as tablet

Arm

Intervention/Treatment

Experimental: ICP-332

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

Drug: ICP-332

ICP-332 will be administered as tablet

Placebo Comparator: Placebo

Single ascending doses of placebo; Multiple ascending doses of placebo

Other: Placebo

Matching placebo will be administered as tablet

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinan Central Hospital	Jinan		China	250013

Sponsors and Collaborators

Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Principal Investigator: Qing Wen, Jinan Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing InnoCare Pharma Tech Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05399030

Other Study ID Numbers:

ICP-CL-00601

First Posted:

Jun 1, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 8, 2022