Healthy
Conditions
Brief summary
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.
Interventions
DRUGEculizumab
Eculizumab Injection. 300 mg, single dose
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent * Have a body weight between 70-95 kg and a body mass index between 20.0-29.9 kg/m² * Have systolic blood pressure (SBP) ≤ 140 and ≥ 90 mmHg, diastolic blood pressure (DBP) ≤ 95 and ≥ 45 mmHg, and pulse rate ≥ 40 and ≤ 100 beats per minute or assessed as not clinically significant * Have physical examination and 12-lead ECG results without clinically significant finding at Screening and Day -1 visits * Non-smoker or smoker whose daily smoking does not exceed 10 cigarettes, 3 cigars, or 3 pipes for at least 30 days prior to Screening visit. Subjects should agree to abstain from smoking while resident at the clinical study site. * Willing to receive vaccination against N. meningitidis at least 14 days prior to IP administration * Male subjects must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception unless their partner is infertile from the time of IP administration until 5 months after IP administration * Must be willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations * Have competence in speaking, writing and comprehending the local language where the study is conducted
Exclusion criteria
* Have a history/presence of clinically significant atopic allergy, allergic/hypersensitive reactions, or known or suspected clinically relevant drug hypersensitivity to eculizumab or its excipients * Contraindication for IP or non-IP to be used in the study * History of N. meningitidis infection * Known or suspected hereditary or acquired complement deficiency * Clinically significant active infection within 28 days before IP administration * Any systemic or local infection, a known risk for developing sepsis and/or known active inflammatory condition * Have previously been exposed to eculizumab (Soliris and its biosimilar) * Previous treatment with a monoclonal antibody or fusion protein within 9 months prior to IP administration and/or have an evidence of immunogenicity from previous exposure to a monoclonal antibody or fusion protein * Have previously been exposed to an immunosuppressive agent or biological agent (any other than a monoclonal antibody or fusion protein) within 120 days prior to IP administration * Any of the following abnormal laboratory values at Screening and Day -1 visits: 1. Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 × ULN 2. Serum C-reactive protein ≥ 10 mg/L 3. Serum creatinine \> 1.5 × ULN 4. Whole blood cell count \< 3000/mm3, absolute lymphocyte count \< 800/mm3, and/or absolute neutrophil count ≤ 1500/mm3 5. Any other laboratory abnormalities assessed as clinically significant by the Investigator * Positive test result for hepatitis B surface antigen and/or hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus at Screening * Surgery within 90 days prior to IP administration, and/or operation during study period * Average intake of alcoholic beverages of more than 21 units/week for males and 14 units/week for females * Drug abuse or a positive urinary drug screening result * Have any prescription medicine or over-the-counter medicines (except paracetamol) that might have an effect on the objectives of the study, within 14 days prior to IP administration * Donated \>100 mL blood or plasma within 28 days prior to IP administration * Subject directly involved in the conduct of the clinical study * Vulnerable subjects * Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf | Day 1 to Day 64 | Area under the concentration-time curve from time zero to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day 1 to Day 64 | Maximum observed serum concentration |
| Tmax | Day 1 to Day 64 | Time to reach Cmax |
| Vz | Day 1 to Day 64 | Volume of distribution during terminal phase |
| λz | Day 1 to Day 64 | Terminal rate constant |
| T1/2 | Day 1 to Day 64 | Terminal half-life |
| AUClast | Day 1 to Day 64 | Area under the concentration-time curve from time zero to the last quantifiable concentration |
| %AUCextrap | Day 1 to Day 64 | Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity |
| Incidence of Treatment-Emergent Adverse Events | Day 1 to Day 64 | Experience at least 1 treatment-emergent adverse event |
| Incidence of Serious Adverse Events | Day 1 to Day 64 | Experience at least 1 serious adverse event |
| Incidence of ADA | Day 1 to Day 64 | Incidence of anti-drug antibodies |
| Incidence NAb | Day 1 to Day 64 | Incidence neutralising antibodies |
| Clearance | Day 1 to Day 64 | Total body clearance |
Countries
Germany
Outcome results
None listed