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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000287033

Enrollment

Registered

2010-04-09

Start date

2010-03-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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 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

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy male subjects having Body Mass Index (BMI) between 19 and 34 kg/m2

Exclusion criteria

Any significant acute or chronic medical condition. Volunteers at risk of tuberculosis(TB). Evidence of organ dysfunction or any clinically significant deviation from normal.

Outcome results