None listed
Conditions
Brief summary
ISU305 is being developed by ISU Abxis as a proposed biosimilar to eculizumab (Soliris® marketed by Alexion in the European Union [Soliris]). Soliris is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) or atypical haemolytic uraemic syndrome (aHUS), disorders associated with dysregulated complement activation.
Interventions
A single intravenous infusion of 300 mg ISU305 will be investigated against a reference product (Soliris).
Sponsors
ISU Abxis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
To be eligible for study entry, subjects must satisfy all of the following criteria: 1. Be able to give voluntary written informed consent prior to any study related procedures before any study-specific procedures are performed; 2. Documented evidence of prior vaccination with meningococcal vaccine for strains A, C W, Y and B (Note: vaccination may take place during the screening period, at least 14 days prior to dosing); 3. Willing to take prophylactic antibiotics (ciprofloxacin 500 mg weekly) for 4 weeks at the study unit, starting on the evening of Day 1 after dosing; 4. Availability for the entire study period and willing to commit to staying for the required time in the study unit; 5. Male subjects aged between 18 years and 45 years; 6. Body mass index (BMI) between 18.00 and 30.00 kg/m2; 7. Weight between 50 kg and 90 kg; 8. A male subject is eligible to participate if he agrees to take appropriate contraceptive measures from Screening and until 5 months after the investigational product administration and refrains from donating sperm for 5 months after the investigational product administration; 9. Subject must be healthy as determined by clinical investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations (haematology, clinical chemistry and urinalysis). Note: physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations must be normal or clinically acceptable as determined by the investigator at all pre-dose assessments.
Exclusion criteria
Subjects will be excluded from the study if one or more of the following criterion are applicable: 1. 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; 2. Proteinuria (with a urine dipstick value of 1+ or above); 3. Known or suspected hereditary complement deficiency; 4. Presence or suspicion of active bacterial infection, in the opinion of the investigator; 5. History of meningococcal infection; 6. 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; 7. History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs; 8. 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; 9. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study; 10. Prior exposure to eculizumab or related compounds (i.e., a monoclonal antibody that specifically binds to the complement protein C5); 11. Known or suspected sensitivity to products derived from mammalian cell lines; 12. Donated blood (including blood products) or experienced loss of blood greater than or equal to 500 mL within 3 months of screening; 13. 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; 14. History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to screening; 15. 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; 16. 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; 17. Positive screen for human immunodeficiency virus (HIV1 and 2), hepatitis B virus surface antigen, or hepatitis C virus; 18. Subjects with a history of migraines, cluster headaches, clinically significant tension headaches or headaches requiring evaluation by a neurologist; 19. History of relevant drug and/or food allergies, and/or latex allergy; 20. 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; 21. 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; 22. Subject is a family member or employee of the investigator/sponsor; 23. History of or current invasive malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years); 24. History of penicillin allergies; 25. History of hypersensitivity to any member of the quinolone class of antimicrobial agents ; 26. History of ongoing seborrheic dermatitis and eczema; 27. 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; 28. 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.
Outcome results
None listed