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

August 5, 2022 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Jinan, China, 250013
        • Jinan Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Treatment-Emergent Adverse Events (AEs).
Time Frame: Baseline up to 28 days after last dose.
Baseline up to 28 days after last dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Maximum concentration (Cmax)
Time Frame: Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14.
Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14.
Change from baseline in blood cells.
Time Frame: Multiple ascending dose: Baseline to 28 days.
measuraments (e.g. blood biochemistry tests, hematology, coagulation tests); outcome measure (e.g. absolute blood cells count)
Multiple ascending dose: Baseline to 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

  • Principal Investigator: Qing Wen, Jinan Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2021

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

February 18, 2022

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ICP-CL-00601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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