Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

NCT04514796 | Completed Phase 1

• 1 other identifier: SB5-1003
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCinf

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

  Day 1 to Day 57

• Cmax

  Maximum serum concentration

  Day 1 to Day 57

Secondary Outcomes (11)

• AUClast

  Day 1 to Day 57

• Tmax

  Day 1 to Day 57

• Vz/F

  Day 1 to Day 57

• λz

  Day 1 to Day 57

• t1/2

  Day 1 to Day 57

Study Arms (2)

40 mg/0.4 mL of SB5

EXPERIMENTAL

100 mg/mL of SB5

Drug: Adalimumab

40 mg/0.8 mL of SB5

ACTIVE COMPARATOR

50 mg/mL of SB5

Drug: Adalimumab

Interventions

Adalimumab DRUG

SB5 (adalimumab), 40 mg, single-dose

40 mg/0.4 mL of SB5; 40 mg/0.8 mL of SB5

Eligibility Criteria

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

You may qualify if:

• Healthy male, aged 18-55 years (inclusive).
• A body weight between 65.0-90.0 kg (inclusive) and a body mass index between 20.0-29.9 kg/m2 (inclusive)
• lead electrocardiogram results without clinically significant abnormal.
• Systolic blood pressure ≤ 140 and ≥ 90 mmHg, diastolic blood pressure ≤ 90 and ≥ 50 mmHg and pulse rate ≥ 45 and ≤ 90 beats per minute or assessed as not clinically significant.
• Physical examination results without clinically significant abnormal findings.
• Clinical laboratory results within the normal range or outside the normal range but assessed as not clinically significant.
• Male subjects who did not have surgical sterilisation 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 such as an intra-uterine device, oral contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation unless their partners are infertile from the time of the investigational product (IP) administration until 5 months after the IP administration.
• Willing and able to comply with study procedures including lifestyle consideration.
• Able to provide written informed consent prior to any study procedures.

You may not qualify if:

• A history and/or current presence of clinically significant atopic, hypersensitivity or allergic, also including known or suspected clinically relevant drug hypersensitivity to adalimumab or to any of the excipients.
• A history of and/or current clinically significant gastrointestinal, renal, hepatic, haematological, pulmonary, neurologic, psychiatric, drug or alcohol abuse, or allergic disease excluding mild asymptotic seasonal allergies.
• Either active or latent tuberculosis (TB) or a history of TB.
• A history of invasive systemic fungal infections or other opportunistic infections.
• A history of any systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process within 180 days prior to Randomisation.
• A sign of ongoing or chronic inflammation process defined as high blood concentration of C reactive protein (\> 1.5 times the upper limit of normal).
• A history of serious infection (associated with hospitalisation and/or which required intravenous antibiotics) within 180 days prior to Randomisation.
• Previously been treated with adalimumab.
• Previously been exposed to a monoclonal antibody or fusion protein (other than adalimumab) within 180 days prior to Randomisation and/or there is a confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
• Previously been exposed to an immunosuppressive agent or biological agent (any other than a monoclonal antibody or fusion protein) within 120 days prior to Randomisation.
• Received live vaccine(s) within 30 days prior to Randomisation or who will require live vaccine(s) during the study period.
• A history of and/or current cardiac disease defined as one of the following:
• Personal or family history of prolonged QT interval syndrome or Torsade de Pointes.
• QT interval corrected by Fridericia's formulas \> 450 msec or PR interval outside the range 120 to 220 msec.
• Signs and symptoms or any history suggestive for heart failure.

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (1)

Parexel International GmbH, Early Phase Clinical Unit Berlin

Berlin, 14050, Germany

Location

Related Publications (1)

• Ahn SS, Lee M, Baek Y, Lee S. A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar). Rheumatol Ther. 2022 Aug;9(4):1157-1169. doi: 10.1007/s40744-022-00471-8. Epub 2022 Jul 1.

  PMID: 35776269 DERIVED

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas Köernicke, MD

  Parexel International GmbH, Early Phase Clinical Unit Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: August 13, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

DE (1)