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

NCT05399030 | Completed Phase 1

• 1 other identifier: ICP-CL-00601
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

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

  Baseline up to 28 days after last dose.

Secondary Outcomes (2)

• 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.

Study Arms (2)

ICP-332

EXPERIMENTAL

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

Drug: ICP-332

Placebo

PLACEBO COMPARATOR

Single ascending doses of placebo; Multiple ascending doses of placebo

Other: Placebo

Interventions

ICP-332 DRUG

ICP-332 will be administered as tablet

ICP-332

Placebo OTHER

Matching placebo will be administered as tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

Jinan Central Hospital

Jinan, 250013, China

Location

Study Officials

• Qing Wen

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 1, 2022
• Study Start: August 14, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 18, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

CN (1)