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A Phase I Study of ICP-022 in Healthy Subjects

NCT03189017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-08-01

No results posted yet for this study

Summary

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.

Conditions

Interventions

DRUG

ICP-022

The drug product is a white, round, uncoated tablet.

DRUG

Placebos

The placebo is a white, round, uncoated tablet.

Sponsors & Collaborators

  • Innocare Pharma Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib · CMAX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2018-02-05
Completion
2018-10-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189017 on ClinicalTrials.gov