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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03597971




Registration number
NCT03597971
Ethics application status
Date submitted
3/05/2018
Date registered
24/07/2018
Date last updated
17/12/2019

Titles & IDs
Public title
HMPL004-6599 Phase I Dose-escalating Study
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 HMPL004-6599 in Healthy Male Volunteers
Secondary ID [1] 0 0
2017-599-00AU1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMPL004-6599
Treatment: Drugs - Placebo

Experimental: Part A: experimental - Subjects will receive HMPL004-6599 or matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).

Placebo comparator: Part A: placebo - Subjects will receive matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule.


Treatment: Drugs: HMPL004-6599
For each cohort, 6 subjects will receive HMPL004-6599

Treatment: Drugs: Placebo
For each cohort, 2 subjects will receive placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Part A: single dose; Part B: 21 days
Primary outcome [2] 0 0
Incidence of Participants with Abnormal Laboratory Values
Timepoint [2] 0 0
Part A: single dose; Part B: 21 days
Secondary outcome [1] 0 0
Maximum Plasma Concentration [Cmax]
Timepoint [1] 0 0
Part A: single dose; Part B: 21 days
Secondary outcome [2] 0 0
Area Under The Concentration Time Curve Up To The Time 't' [AUC0-t]
Timepoint [2] 0 0
Part A: single dose; Part B: 21 days
Secondary outcome [3] 0 0
Time of Maximum Plasma Drug Concentration [Tmax]
Timepoint [3] 0 0
Part A: single dose; Part B: 21 days
Secondary outcome [4] 0 0
Area Under The Concentration Time Curve Up To The Last Data Point Above LOQ [AUClast]
Timepoint [4] 0 0
Part A: single dose; Part B: 21 days
Secondary outcome [5] 0 0
Apparent Half-Life For Designated Elimination Phases [t1/2]
Timepoint [5] 0 0
Part A: single dose; Part B: 21 days
Secondary outcome [6] 0 0
Area Under The Concentration-Time Curve During Once Dosing Interval [AUCTau or AUC0-_]
Timepoint [6] 0 0
Part B: 21 days
Secondary outcome [7] 0 0
Minimum Observed Concentration [Cmin]
Timepoint [7] 0 0
Part B: 21 days
Secondary outcome [8] 0 0
Average Concentration [Cavg]
Timepoint [8] 0 0
Part B: 21 days
Secondary outcome [9] 0 0
%_Fluctuation
Timepoint [9] 0 0
Part B: 21 days
Secondary outcome [10] 0 0
Accumulation Ratio_obs
Timepoint [10] 0 0
Part B: 21 days

Eligibility
Key inclusion criteria
Subjects must meet all the following for inclusion in the trial:

1. Informed consent must be obtained in writing for all subjects before enrollment into the study.
2. Healthy male subjects aged 18 to 45 years inclusive at the time of screening.
3. Body mass index =19.0 and = 30.0 kg/m2
4. No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems.
5. No clinically significant laboratory values and urinalysis, as determined by the Clinical Investigator.
6. No clinically significant findings in ECG, blood pressure and heart rate, as determined by the Clinical Investigator.
7. Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study and for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 3 months afterwards.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects presenting with any of the following will not be included in the study:

1. Family history of premature Coronary Heart Disease
2. History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening.
3. Subjects at risk for tuberculosis (TB), specifically subjects with:

1. Clinical or laboratory evidence of active TB
2. History of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type
3. Latent TB which has not been successfully treated
4. History of hypertension requiring treatment.
5. Any condition requiring the regular use of any medication.
6. Exposure to prescription medications within 30 days prior to Day 1.
7. Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to first dose (except for paracetamol).
8. Participation in another study with any investigational drug in the 30 days preceding Day 1 of the study or in the exclusion period of any previous study with investigational drugs.
9. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Once-off medication such as paracetamol or any medication deemed not clinically significant by the principal investigator can be permitted.
10. Current smoker of more than 10 cigarettes or equivalent / day during past 3 months prior to commencing the study and unable to completely stop smoking during the study.
11. Symptoms of a clinically significant illness in the 3 months before the study.
12. Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
13. Chronic constipation or diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), Hemorrhoids or anal diseases with regular or recent presence of blood in feces.
14. History of significant allergic disease (e.g. Allergic to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization/enrollment or any food allergy.
15. Blood or plasma donation of no more than 470 ml during the past 30 days (equivalent to the standard blood donation in Australia) before randomization/enrollment and/or more than 50 ml in the 2 weeks prior to screening.
16. Known positive test for human immunodeficiency virus (HIV).
17. Known positive test for hepatitis B or C, unless caused by immunization.
18. Current evidence of drug abuse or history of drug abuse within one year before randomization/enrollment.
19. History of alcohol abuse or active alcoholism with average weekly alcohol intake that exceeds 21 units.
20. Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study.
21. Adults under guardianship and people with restriction of freedom by administrative or legal decisions.
22. 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.
23. 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.
24. Known allergy to plants of the Acanthaceae family.
25. Those Subjects who are Vegetarian due to the requirements of the Standard Meal.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2018
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nutrition Science Partners Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hutchison Medipharma Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Société des Produits Nestlé (SPN)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Wu Yan, MD
Address 0 0
Hutchison Medipharma Limited
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03597971