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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02105129




Registration number
NCT02105129
Ethics application status
Date submitted
19/03/2014
Date registered
7/04/2014
Date last updated
28/04/2016

Titles & IDs
Public title
A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523
Scientific title
A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523
Secondary ID [1] 0 0
2014-523-00AU1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMPL-523
Treatment: Drugs - Placebo

Experimental: HMPL-523 - Single/Multiple Ascending Dose. oral administration, a single dose of 5, 20, 50, 100, 200 and 300 mg (Part A) and multiple dose of HMPL-523 at dose level based on result of Part A

Placebo Comparator: Placebo - Placebo: oral administration


Treatment: Drugs: HMPL-523
HMPL-523: Oral administration with a single dose of 5, 20, 50, 100, 200 and 300 mg in Part A, followed by multiple doses of selected strength in Part B Other Name: NA

Treatment: Drugs: Placebo
Oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
To measure the plasma concentration of HMPL-523 in single and repeated doses
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- Informed consent must be obtained in writing for all subjects before enrollment into
the study

- Healthy male subjects aged 18 to 45years inclusive at the time of screening

- Body mass index =19.0 and = 30.0 kg/m2

- No clinically significant abnormalities as determined by medical history and physical
examination, especially with regard to the liver, bile and gastrointestinal systems

- No clinically significant laboratory values and urinalysis, as determined by the
clinical Investigator.

- No clinically significant findings in ECG, blood pressure and heart rate, as
determined by the clinical Investigator.

- Willing to comply with the contraceptive requirements of the study and must not donate
sperm during the study or for 3 months afterwards. Subjects must agree to use a condom
or to abstain from sexual intercourse throughout the trial and for 30 days afterwards.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Family history of premature Coronary Heart Disease

- Any condition requiring the regular use of any medication

- Exposure to prescription medications or to drugs known to interfere with metabolism of
drugs within 30 days prior to Day 1

- Exposure to any other medication, including over-the counter medications, herbal
remedies and vitamins 14 days prior to first dose

- Participation in another study with any investigational drug in the 30 days preceding
Day 1 of the study

- Treatment in the previous 3 months with any drug known to have a well defined
potential for toxicity to a major organ

- Current smoker of more than 10 cigarettes or equivalent / day prior to commencing the
study and unable to completely stop smoking during the study

- Be in the exclusion period of any previous study with investigational drugs

- Symptoms of a clinically significant illness in the 3 months before the study

- Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions
known to interfere with the absorption, distribution, metabolism, or excretion of
drugs

- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel
disease, Hemorrhoids or anal diseases with regular or recent presence of blood in
feces

- History of significant allergic disease (e.g. Allergic to medications) and acute phase
of allergic rhinitis in the previous 2 weeks before randomization or any food allergy

- Blood or plasma donation of more than 500 ml during the previous 30 Days before
randomization and/or more than 50 ml in the 2 weeks prior to screening

- Known positive test for HIV

- Known positive test for hepatitis B or C, unless caused by immunization

- Current evidence of drug abuse or history of drug abuse within one year before
randomization

- History of alcohol abuse or active alcoholism as defined in Appendix A Definition of
alcohol abuse

- Mental condition rendering the subject incapable to understand the nature, scope, and
possible consequences of the study

- Adults under guardianship and people with restriction of freedom by administrative or
legal decisions

- Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude,
inability to return for follow-up visits, and improbability of completing the study

- Subject is the investigator or any sub-investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct of
the protocol

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hutchison Medipharma Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to assess the safety and tolerability of a single dose
of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under
fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a
standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B,
in healthy male volunteers.

The secondary objective is to determine the pharmacokinetic profile of single (Part A) and
multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the
preliminary effect of food (Part C)
Trial website
https://clinicaltrials.gov/ct2/show/NCT02105129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MD
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02105129