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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT03944460
Eligibility Criteria:
Inclusion Criteria:
* With clinical history and physical examination results within normality.
* Electrocardiogram without clinically significant pathologic abnormalities and with QTc values lesser than 450 ms.
* Normotensive as defined by Systolic Blood Pressure ≤ 150 mm Hg. Diastolic Blood Pressure ≤ 90 mm Hg.
* BMI between 19.0 and 30.0 kg/m2.
* Body weight between 55 and 85 kg, inclusive
* Signed ICF
Exclusion Criteria:
* Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound the interpretation of safety observations.
* Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.
* Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
* History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
* Seropositive for human immunodeficiency virus (HIV).
* History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen \[HbsAg\] or anti-Hepatitis C \[HCV\] antibody).
* Clinically significant abnormalities in screening laboratory tests, including:
* Absolute neutrophil count \< 1.4 x109
* Alanine transaminase (ALT) or aspartate transaminase (AST) \> 1.5 x the upper limit of normal (ULN)
* Absolute lymphocyte count \< 1.2 x 109
* Lactate dehydrogenase (LDH) \> 1.5 x ULN
* Total bilirubin level: Out of normal range 0-1.5 mg/dL
* eGFR \< 60 mL/min
* Hemoglobin (Hgb): out of normal range (male: 13,5-18,0 g/dL)
* CK level higher than normal values (250U/L)
* All prescription, over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements, nasal steroids, ocular medications, and paracetamol ≤1000 mg/day at the discretion of the Investigator).
* Use of an investigational drug within 2 months prior to dosing in this study.
* Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease.)
* Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.
* History of substance abuse, including alcohol
* Smokers
* History of substance or drug dependence, or positive urine drug screen at screening visit.
* History of head injury.
* Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of \<60 ml/min using the MDRD formula).
* Any reason or opinion of the investigator that would prevent the subject from participation in the study.
* Inability to follow the instructions or an unwillingness to collaborate during the study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03944460
Study Brief:
Protocol Section:
NCT03944460