A randomised, double-blind, single-dose study to evaluate the pharmacokinetic, safety, tolerability, immunogenicity and pharmacodynamic profile of ISU305 compared to Soliris® (Eculizumab) in Healthy Male Volunteers

Exclusion Criteria29

• Subjects will be excluded from the study if one or more of the following criterion are applicable:
• Hypertension (defined as a systolic blood pressure > 140 mmHg and/or a diastolic blood pressure > 90 mmHg confirmed by a single repeat measurement that same day) or a history of hypertension requiring intervention;
• Proteinuria (with a urine dipstick value of 1+ or above);
• Known or suspected hereditary complement deficiency;
• Presence or suspicion of active bacterial infection, in the opinion of the investigator;
• History of meningococcal infection;
• History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator and medical monitor or designee, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
• History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs;
• Use of any over the counter (OTC) or prescription medications within the 14 days or 5 half-lives (whichever is longer), prior to receiving investigational product. Acetaminophen/paracetamol (up to 4 g per day) for analgesia will be allowed. Previous immunoglobulin or iron supplementation within 3 months prior to the screening visit is not allowed. Vitamin and herbal medicines use can be allowed per agreement between the investigator and the medical monitor, and communicated to the Sponsor;
• History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study;
• Prior exposure to eculizumab or related compounds (i.e., a monoclonal antibody that specifically binds to the complement protein C5);
• Known or suspected sensitivity to products derived from mammalian cell lines;
• Donated blood (including blood products) or experienced loss of blood greater than or equal to 500 mL within 3 months of screening;
• Positive screen for alcohol and/or potential drugs of abuse (cannabis and metabolites, cocaine and metabolites, amphetamines, barbiturates, benzodiazepines and opioids) by urine drug screen. A positive screen may be repeated once at the discretion of the investigator;
• History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to screening;
• Smokes >10 cigarettes per day within 3 months of screening or is not able to refrain from smoking during the inpatient component of the study;
• Subject should refrain from drinking alcohol within 72 hours prior to Day -1, and should not consume more than 14 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) throughout the study;
• Positive screen for human immunodeficiency virus (HIV1 and 2), hepatitis B virus surface antigen, or hepatitis C virus;
• Subjects with a history of migraines, cluster headaches, clinically significant tension headaches or headaches requiring evaluation by a neurologist;
• History of relevant drug and/or food allergies, and/or latex allergy;
• Vaccination within 30 days prior to entry into the study except study required meningococcal vaccination or planning a vaccination before the Day 57 end of study visit;
• Positive result for tuberculosis using QuantiFERON-TB Gold test at the screening visit or, if indeterminant result on first test, positive or indeterminant on repeat QuantiFERON-TB Gold test;
• Subject is a family member or employee of the investigator/sponsor;
• History of or current invasive malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years);
• History of penicillin allergies;
• History of hypersensitivity to any member of the quinolone class of antimicrobial agents ;
• History of ongoing seborrheic dermatitis and eczema;
• Known hypersensitivity to any component of Bexsero and Menactra including diphtheria toxoid, or a life-threatening reaction after previous administration of a vaccine containing similar components;
• Receiving or has received other investigational drugs (or is currently using an investigational device) within 3 months or 5 half-lives (whichever is longer) prior Day 1.