Ascending single doses of a novel Interlukin (IL-1 ) agonist administered to healthy subjects.

Phase 1

• Conditions: Auto-immune inflammatory disease; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12609000891224
• Lead Sponsor: Hutchison MediPharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single doses of HMPL-011 at 10,50, 200, 400 and 800 mgs will be assessed on the basis of adverse events reported, blood pressure, heart rate, body temperature (oral), electrocardiograms(ECGs), clinical laboratory tests and physical examination.These methods used will be medical equipment and questionning.[Subjects will be continuously monitored for adverse events, blood pressure, heart rate, body temperature, electrocardiograms(ECGs), clinical laboratory tests and physical examination whilst on study.]

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic profile of HMPL-011 at 10, 50,200, 400 and 800 mgs by blood analysis[The pharmacokinetics of HMPL-011 will be measured at predetermined timepoints throughout the study.these time points are: pre-dose, 25 mins, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs after administration of drug/placebo.]