Skip to main content
OpenTrials
Completed

NCT Number: NCT05399030

A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jinan Central Hospital

Jinan, 250013, China

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ICP-332

Drug

ICP-332 will be administered as tablet

Placebo

Other

Matching placebo will be administered as tablet

Primary outcomes

  1. Number of participants with Treatment-Emergent Adverse Events (AEs).

    Time frame: Baseline up to 28 days after last dose.

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2022
Registry last updated
Aug 8, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.