Phase
Condition
Inflammatory Bowel Disease
Memory Loss
Multiple Sclerosis
Treatment
ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject age between 18 to 55 years old.
Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.
Subject is able to complete the clinical study including the follow-up.
Subject is capable of providing written informed consent.
Exclusion
Exclusion Criteria:
Breastfeeding female.
Pregnancy test positive female.
At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressureoutside 50-90 mmHg.
At rest sinus bradycardia defined as symptomatic heart rate < 50 bpm, orasymptomatic heart rate < 45 bpm; and sinus tachycardia defined as heart rate > 100 bpm.
Clinically significant ECG abnormalities or Participant with history or presence ofsecond-degree atrioventricular (AV) block Type II or third-degree AV block or sicksinus syndrome unless the patient has a functioning pacemaker.
QTc > 450 ms for male and > 460 ms for female.
A history of allergies, or any significant adverse reactions, to any medications,unless the clinician considers that they are not clinically significant.
Clinically significant medical history of eyes, ears, nose, throat, respiratory,cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic,lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological,family history or surgical history.
Family history of sudden cardiac death.
Clinically significant physical examination finding.
Clinically significant laboratory abnormalities.
Haemoglobin < 12.0 g/dL for male and < 11.0 g/dL for female atscreening.
Total bilirubin > 1.25 x upper limit of normal (unless it is an isolatedelevation where the direct bilirubin is ≤ 35% of total), ALT/AST > 1.5 xupper limit of normal, or CK > 2 x upper limit of normal.
Hepatitis B, Hepatitis C or HIV positive.
Urine DOA test positive.
Breath alcohol test positive.
Any use of tobacco product(s) 30 days prior to study recruitment.
A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint [285mL] of beer, 1 glass [125 mL] of wine, or 1 shot [25 mL] of spirit).
Unable to refrain from taking any medications (including herbal remedies) within 7days before dosing, with the exception of birth control medications and othermedications deemed acceptable by the Investigator.
Clinically significant illness or injury or hospitalisation for any reason within 28days before consent-taking.
Unable to refrain or has participation in other clinical study involving a marketedor investigational drug within 28 days or 10 half-lives of the drug before dosing,whichever is longer.
Unable to refrain or has donation of > 500 mL of plasma within 14 days beforedosing; or donation or loss of whole blood (excluding the amount of blood collectedduring screening) before dosing as follows:
50-300 mL within 28 days,
301-500 mL within 42 days, or
> 500 mL within 84 days.
Any upper arm conditions that will disallow study drug administration or difficultyto swallow the study drug.
Any other medical condition or reason that, in the opinion of the Investigator orResearch Physician, makes the subject unsuitable to participate in the clinicalstudy.
Unable to refrain from taking any of the following systemic medications: Strong inhibitors of CYP3A, and all inhibitors of CYP2C8 or BCRP, (i.e.,cyclosporine eltrombopag, geftinib) within 7 days or 5 half-lives, whichever islonger, prior to dosing or Strong inducers of CYP3A, and all inducers of CYP2C8within 14 days or 5 half-lives, whichever is longer, prior to dosing, or Any knownMAO inhibitors within 30 days or 5 half-lives, whichever is longer, prior to Day 1. Examples of MAO inhibitors include but are not limited to phenelzine, selegiline,isocarboxazid, rasagiline, tranylcypromine, pargyline, procarbazine, andfurazolidone.
Female of childbearing potential unable to refrain from having unprotected sexualintercourse with any non-sterile male partner within 14 days before dosing;acceptable methods of contraception include:
double barrier (1 by each partner), and at least 1 of these barriers (condom,cervical cap, diaphragm or sponge) must contain spermicide,
hormonal (oral, injectable, transdermal, intravaginal or implantable),
intrauterine contraceptive system,
surgical (vasectomy or tubal ligation), or
sexual abstinence.
Study Design
Study Description
Connect with a study center
Hospital Ampang
Ampang, Selangor 1733037 68000
MalaysiaSite Not Available

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