HMPL004-6599 Phase I Dose-escalating Study

This is an interventional treatment trial for Ulcerative Colitis Read More

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.

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.