RecruitingPhase 1ACTRN12610000287033

Ascending multiple doses of a novel Interluken(IL-1) agonist administered to healthy subjects

A phase I randomized, double-blind, placebo-controlled study in healthy male volunteers to examine the safety, tolerability, and pharmacokinetics of HMPL-011 after multiple dosing for 14 days.


Sponsor

Hutchison MediPharma

Enrollment

24 participants

Start Date

Mar 30, 2010

Study Type

Interventional

Conditions

Summary

HMPL-011, the Hutchison MediPharma study drug, is an experimental compound being investigated for its potential to control how the body responds to certain inflammatory processes found in a number of autoimmune diseases such as rheumatoid arthritis. It is hoped that this information will lead to an improved anti-inflammatory drug which could reduce the inflammation responsible for the damage to the body’s organs caused by these diseases (such as the joint destruction seen in rheumatoid arthritis).


Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is testing a new experimental drug called HMPL-011 in healthy men to see if it is safe at different doses. The drug is being developed to reduce inflammation in autoimmune diseases like rheumatoid arthritis, where the immune system attacks the body's own joints. Before a drug can be tested in patients with disease, it must first be shown to be safe in healthy volunteers. You may be eligible if: - You are a healthy male between 18 and 45 years old - Your body mass index (BMI) is between 19 and 34 kg/m² You may NOT be eligible if: - You have any significant acute or chronic medical condition - You are at risk of tuberculosis (TB) - You have signs of organ damage or any significant abnormal lab results Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Multiple ascending doses of a novel iL-10 agonist administered to healthy subjects. In the multiple ascending dose 8 subjects in cohort 1 and 2, will receive twice daily doses of test medication (or p

Multiple ascending doses of a novel iL-10 agonist administered to healthy subjects. In the multiple ascending dose 8 subjects in cohort 1 and 2, will receive twice daily doses of test medication (or placebo) for 14 days as a oral solution in a double-blind manner.In cohort 3 a daily dose of test medication (or placebo) in a double-blind manner under fed and fasted conditions for 14 days. Cohort 1: 200 mg twice daily Cohort2: 300mg twice daily Cohort3: 600mg daily. The duration of each cohort is 14 days postdose.


Locations(1)

Australia

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ACTRN12610000287033