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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02474134
Eligibility Criteria:
Inclusion Criteria:
* Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
* Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
* Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
* Able to understand and sign the written Informed Consent Form
Exclusion Criteria:
* Female subjects who are pregnant or lactating.
* History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
* Previous treatment with any interferon product, including investigational use.
* Participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
* Positive screening test for human immunodeficiency virus (HIV).
* Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis surface antigen \[HBsAg\] at Screening). Participants with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody \[HBsAb\]) are eligible to participate in the study.
* History of epilepsy, seizure disorder or any unexplained black-outs.
* History of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (NSAID) that would preclude the use of at least 1 of these during the study.
* History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
* History of drug or alcohol abuse less than or equal to 12 months prior to Screening.
* History of tobacco use less than or equal to 6 months prior to Screening.
* A positive test for drugs of abuse or alcohol during Screening or prior to dosing.
* Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
* Use of any prescription medication, over-the-counter medication, or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the Sponsor.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02474134
Study Brief:
Protocol Section:
NCT02474134