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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02235727
Eligibility Criteria:
Inclusion Criteria:
1. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
2. Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
3. Subjects who are otherwise healthy and free from clinically significant illness or disease as determined by medical history, vital signs, physical examinations, and other tests performed by the investigator.
Exclusion Criteria:
1. Subjects with a history of neuropathy or otherwise present with risk factors for neurological toxicity like chronic alcoholism or clinically significant neurological (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.
2. Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
3. Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
4. Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
5. Subjects with a current and/or recent history of arthralgia or a history of fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.
6. Any evidence of organ dysfunction or any clinically significant deviation from the normal in history, physical or neurological determinations or investigations or has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02235727
Study Brief:
Protocol Section:
NCT02235727