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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Eculizumab

• Registration Number: NCT03722329
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Study Start: 2018-11-13
• Primary Completion: 2019-03-29
• Study Completion: 2019-04-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB12	Eculizumab	SB12 (proposed eculizumab biosimilar)
US Soliris	Eculizumab	US sourced Soliris (eculizumab)
EU Soliris	Eculizumab	EU sourced Soliris (eculizumab)

Primary Outcome Measures

Name	Time	Method
AUCinf	Day 1 to Day 64	Area under the concentration-time curve from time zero to infinity

Secondary Outcome Measures

Name	Time	Method
Vz	Day 1 to Day 64	Volume of distribution during terminal phase
Clearance	Day 1 to Day 64	Total body clearance
Incidence of ADA	Day 1 to Day 64	Incidence of anti-drug antibodies
%AUCextrap	Day 1 to Day 64	Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity
Incidence of Serious Adverse Events	Day 1 to Day 64	Experience at least 1 serious adverse event
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
Cmax	Day 1 to Day 64	Maximum observed serum concentration
Tmax	Day 1 to Day 64	Time to reach Cmax
λz	Day 1 to Day 64	Terminal rate constant
Incidence of Treatment-Emergent Adverse Events	Day 1 to Day 64	Experience at least 1 treatment-emergent adverse event
Incidence NAb	Day 1 to Day 64	Incidence neutralising antibodies

Trial Locations

Locations (1)

PAREXEL International GmbH, Early Phase Clinical Unit - Berlin; 🇩🇪 Berlin, Germany