Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT01992367
Eligibility Criteria:
Inclusion Criteria:
* The inclusion criteria for all subjects are as follows:
* are capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
* are able to communicate well with the Investigator, and understand and comply with the requirements of the study;
* male subjects aged between 21 and 50 years, inclusive (Part A and Cohorts 5, 6 and 7 of Part B only); male subjects and female subjects of non childbearing potential aged ≥55 years (Cohort 8 of Part B only);
* body mass index (BMI) in the range of 18 to 30 kg/m2, inclusive;
* healthy, as determined by pre study medical history, physical examinations, vital sign measurements, electrocardiogram (ECG; 12 lead reporting RR, PR, QRS, corrected QT \[QTc\] and QT interval corrected for heart rate using Fridericia's formulas \[QTcF\]) recordings with no evidence of clinically relevant medical disorders based on the opinion of the Investigator;
* whose out-of-normal range clinical laboratory test results are not clinically relevant and are acceptable to the Investigator;
* male subjects must be willing to use barrier contraception during sexual intercourse, i.e. condoms, even if their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods, from the first day of dose administrations until 3 months after the last dose administration;
Exclusion Criteria:
* The exclusion criteria for all subjects are as follows:
* have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;
* history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;
* history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP;
* clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.);
* active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum);
* active or history of psoriasis, or a first-degree relative with active or history of psoriasis;
* known history or evidence of active or latent tuberculosis infection (e.g. positive tuberculin skin test showing induration \>5 mm or positive tuberculin blood test) in absence of previous Bacillus Calmette Guerin vaccination, or recent exposure (within 6 months prior to randomisation in this study) to an individual with active tuberculosis or with intention to travel to a country with a high risk of tuberculosis during the study period (including the follow up period);
* history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia;
* with QT or QTcF values higher than 450 ms at screening;
* history of regular alcohol consumption (within 6 months prior to randomisation in this study), defined as: an average weekly intake of greater than 21 units or any average daily intake of greater than 3 units. One unit is equivalent to a half pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine;
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT01992367
Study Brief:
Protocol Section:
NCT01992367