Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000287033
Ethics application status
Approved
Date submitted
24/03/2010
Date registered
9/04/2010
Date last updated
9/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ascending multiple doses of a novel Interluken(IL-1) agonist administered to healthy subjects
Scientific title
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.
Secondary ID [1] 1557 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
auto-immune inflammatory disease 256891 0
Condition category
Condition code
Inflammatory and Immune System 257039 257039 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256087 0
Treatment: Drugs
Comparator / control treatment
The placebo is citric acid solution. Both the interventional drug and placebo are admistered orally as a solution.
Control group
Placebo

Outcomes
Primary outcome [1] 258077 0
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.
No specific adverse events are expected.
Timepoint [1] 258077 0
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 [1] 263659 0
To determine the Pharmacokinetic profile of HMPL-011 at 200mg twice daily, 300mg twice daily and 600mg by blood analysis
Timepoint [1] 263659 0
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.

Eligibility
Key inclusion criteria
Healthy male subjects having Body Mass Index (BMI) between 19 and 34 kg/m2
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256697 0
Commercial sector/Industry
Name [1] 256697 0
Hutchison MediPharma
Country [1] 256697 0
China
Primary sponsor type
Commercial sector/Industry
Name
Hutchison MediPharma
Address
Building 4, 720 Cai Lun Road, Z.J.Hi-Tec Park, Shanghai, China, 201203
Country
China
Secondary sponsor category [1] 255984 0
None
Name [1] 255984 0
Address [1] 255984 0
Country [1] 255984 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30884 0
Address 30884 0
Country 30884 0
Phone 30884 0
Fax 30884 0
Email 30884 0
Contact person for public queries
Name 14131 0
Mary Franich
Address 14131 0
Centre for Clinical Studies
5th Floor Burnett Tower, AMREP Precinct,
89 Commercial Road, Melbourne,Victoria, 3004
Country 14131 0
Australia
Phone 14131 0
1800 243 733
Fax 14131 0
61 3 9076 8911
Email 14131 0
[email protected]
Contact person for scientific queries
Name 5059 0
Associate Professor Peter Hodsman
Address 5059 0
Centre for Clinical Studies
5th Floor Burnett Tower, AMREP Precinct,
89 Commercial Road, Melbourne,Victoria, 3004
Country 5059 0
Australia
Phone 5059 0
613 9076 8900
Fax 5059 0
613 9076 8911
Email 5059 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.