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

NCT03722329 | Completed Phase 1 FDA Drug

• 1 other identifier: SB12-1001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUCinf

  Area under the concentration-time curve from time zero to infinity

  Day 1 to Day 64

Secondary Outcomes (12)

• AUClast

  Day 1 to Day 64

• Cmax

  Day 1 to Day 64

• Tmax

  Day 1 to Day 64

• Vz

  Day 1 to Day 64

• λz

  Day 1 to Day 64

Study Arms (3)

SB12

EXPERIMENTAL

SB12 (proposed eculizumab biosimilar)

Drug: Eculizumab

EU Soliris

ACTIVE COMPARATOR

EU sourced Soliris (eculizumab)

Drug: Eculizumab

US Soliris

ACTIVE COMPARATOR

US sourced Soliris (eculizumab)

Drug: Eculizumab

Interventions

Eculizumab DRUG

Eculizumab Injection. 300 mg, single dose

EU Soliris; SB12; US Soliris

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 × ULN
• Serum C-reactive protein ≥ 10 mg/L
• Serum creatinine \> 1.5 × ULN
• Whole blood cell count \< 3000/mm3, absolute lymphocyte count \< 800/mm3, and/or absolute neutrophil count ≤ 1500/mm3
• Any other laboratory abnormalities assessed as clinically significant by the Investigator

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (1)

PAREXEL International GmbH, Early Phase Clinical Unit - Berlin

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

eculizumab

Study Officials

• Rainard Fuhr, MD

  PAREXEL International GmbH, Early Phase Clinical Unit - Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 26, 2018
• Study Start: November 13, 2018
• Primary Completion: March 29, 2019
• Study Completion: April 8, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

DE (1)