Ascending multiple doses of a novel Interluken(IL-1) agonist administered to healthy subjects
Phase 1
Recruiting
- Conditions
- auto-immune inflammatory diseaseInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12610000287033
- Lead Sponsor
- Hutchison MediPharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of multiple doses of HMPL-011 at 200mg twice daily, 300mg twice daily and 600mg daily 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 questioning.<br>No specific adverse events are expected.[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 (from baseline to Day 15).]
- Secondary Outcome Measures
Name Time Method To determine the Pharmacokinetic profile of HMPL-011 at 200mg twice daily, 300mg twice daily and 600mg by blood analysis[The pharmacokinetics of HMPL-011 will be collected at predetermined timepoints throughout the study and measured after each cohort. These time points are: pre-dose, 30 mins, 1,2,4,6,8,10,12,12.5,13,14,16, and 24hrs after administration of drug/placebo on Day 1 and 14.]