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OpenTrials
Completed

NCT Number: NCT06530966

Phase I Study of ICP-332 in Healthy Subjects

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC Inc.

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ICP-332 Tablets

Drug

Eligible patients will receive ICP-332 tablets orally as per the protocol

ICP-332 placebo Tablets

Drug

Eligible patients will receive ICP-332 placebo tablets orally as per the protocol

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 28

  2. Number of Participants With Clinically Significant Change in Vital Signs

    Time frame: Up to Day 28

  3. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)

    Time frame: Up to Day 28

  4. Number of Participants With Clinically Significant Change in Physical Examination

    Time frame: Up to Day 28

  5. Number of Participants With Clinically Significant Change in Clinical Laboratory Values

    Time frame: Up to Day 28

Sponsors and collaborators

Lead sponsor

InnoCare Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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