A Phase I Study of ICP-022 in Healthy Subjects

Rheumatoid Arthritis Clinical Trial

Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a single center, randomized, double-blind, dose escalation, placebo-controlled, first-in-humans phase 1 study to investigate the safety and tolerability of single and multiple escalating doses of ICP-022 in healthy volunteers. 40 healthy male participants (aged between 18 and 55 years of age inclusive) will be enrolled into Part 1 (single escalating dose administration) of this study, and additional 24 male subjects will be enrolled in Part 2 (multiple escalating dose administration). Part 1a consists of 5 cohorts of 8 participants each, while Part 2 includes 3 cohorts of 8 participants each.

Part 1a consists a treatment period with single oral dosing, and a safety follow-up to 7 days after dosing. Cohort 4 of Part 1a will return on Day 8 to repeat the study under fed condition in Part 1b.

Part 2 consists a treatment period with multiple dosing (once per day for 14 consecutive days), and a safety follow-up until 28 days after dosing. All subjects will receive either ICP-022 or placebo. ;

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Lupus Erythematosus, Systemic
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

• NCT number: NCT03189017
• Study type: Interventional
• Source: Innocare Pharma Australia Pty Ltd
• Status: Completed
• Phase: Phase 1
• Start date: July 3, 2017
• Completion date: October 30, 2018