Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

• Status: Completed
• Trial end date: 2019-04-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samsung Bioepis Co., Ltd.
• Treatments: Eculizumab

Criteria

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