Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000891224
Ethics application status
Not yet submitted
Date submitted
28/09/2009
Date registered
12/10/2009
Date last updated
12/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Ascending single doses of a novel Interlukin (IL-1 ) agonist administered to healthy subjects.
Scientific title
Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial in Healthy Male Volunteers To Examine The Safety, Tolerability, And Pharmacokinetics Of HMPL-011 After A Single Dose
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auto-immune inflammatory disease 251925 0
Condition category
Condition code
Inflammatory and Immune System 252110 252110 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ascending single doses of a novel IL-10 agonist administered to healthy subjects.
In the single ascending dose 8 subjects, will receive single oral dose of test medication (or placebo ) in a double-blind manner.
Doses will be:
Cohort 1: 10 mg
Cohort 2: 50 mg
Cohort 3: 200 mg
Cohort 4: 400 mg
Cohort 5: 800 mg
The duration of each cohort is 2 days postdose, with a single dose administered on Day 1.
Intervention code [1] 241348 0
Treatment: Drugs
Comparator / control treatment
The placebo is citric acid solution. Both the interventonal drug and the placebo are administered orally
Control group
Placebo

Outcomes
Primary outcome [1] 252990 0
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.
Timepoint [1] 252990 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.
Secondary outcome [1] 257757 0
To determine the pharmacokinetic profile of HMPL-011 at 10, 50,200, 400 and 800 mgs by blood analysis
Timepoint [1] 257757 0
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.

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 conditions. Subjects 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
Not yet recruiting
Date of first participant enrolment
Anticipated
19/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243804 0
Commercial sector/Industry
Name [1] 243804 0
Hutchison MediPharma
Country [1] 243804 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] 237156 0
None
Name [1] 237156 0
Address [1] 237156 0
Country [1] 237156 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243935 0
Ethics committee address [1] 243935 0
Ethics committee country [1] 243935 0
Date submitted for ethics approval [1] 243935 0
02/09/2009
Approval date [1] 243935 0
Ethics approval number [1] 243935 0

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

Contacts
Principal investigator
Name 30334 0
Address 30334 0
Country 30334 0
Phone 30334 0
Fax 30334 0
Email 30334 0
Contact person for public queries
Name 13581 0
Mary Franich
Address 13581 0
Centre for Clinical Studies
5th Floor Burnet Tower, AMREP Precinct, 89 Commercial Road, Melbourne, Victoria, 3004
Country 13581 0
Australia
Phone 13581 0
1800 243 733
Fax 13581 0
61 3 9076 8911
Email 13581 0
[email protected]
Contact person for scientific queries
Name 4509 0
Associate Professor Peter Hodsman
Address 4509 0
Centre for Clinical Studies
5th Floor Burnet Tower, AMREP Precinct, 89 Commercial Road, Melbourne, Victoria, 3004
Country 4509 0
Australia
Phone 4509 0
613 9076 8900
Fax 4509 0
61 3 9076 8911
Email 4509 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.