Phase I Study of ICP-332 in Healthy Subjects

April 12, 2026 updated by: InnoCare Pharma Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-332 in Healthy Subjects

A multiple ascending dose phase I study of ICP-332 in healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pharmaron CPC Inc.

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Voluntarily sign the informed consent form
  2. Body mass index (BMI) of ≥ 18.5 kg/m2 and < 30 kg/m2
  3. Male or infertile female subjects who are between 18-55 years old (inclusive)

Exclusion Criteria:

  1. Significant current or past acute or chronic disease or condition.
  2. A history of tuberculosis or current active/latent infection.
  3. With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
  4. Subjects with clinically significant abnormalities in the screening examinations.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: ICP-332 Placebo Tablets
Eligible patients will receive ICP-332 placebo tablets orally as per the protocol
Experimental: ICP-332
Drug: ICP-332 Tablets
Eligible patients will receive ICP-332 tablets orally as per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: Up to Day 28
Up to Day 28
Number of Participants With Clinically Significant Change in Vital Signs
Time Frame: Up to Day 28
Up to Day 28
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Time Frame: Up to Day 28
Up to Day 28
Number of Participants With Clinically Significant Change in Physical Examination
Time Frame: Up to Day 28
Up to Day 28
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Time Frame: Up to Day 28
Up to Day 28

Collaborators and Investigators

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

Sponsor

InnoCare Pharma Inc.

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)

July 23, 2024

Primary Completion (Actual)

November 8, 2024

Study Completion (Actual)

November 8, 2024

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

July 28, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ICP-CL-00605

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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