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AzTrials

HealthyPhase 1NCT04514796

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

A Phase 1 study testing Adalimumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteGermany
Study dates
13 Aug 2020to 15 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
  • 12-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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Any other cardiac abnormalities or conditions assessed as clinically significant.
  • Impaired liver, pancreas and biliary system as determined by one of the following:
  • Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 times the upper limit of normal.
  • Gallbladder or bile duct disease classified as clinically significant.
  • Acute or chronic pancreatitis.
  • A positive hepatitis C virus antibody test or hepatitis B virus surface antigen test, or signs for active or chronic hepatitis B.
  • Hepatic disease classified as clinically significant.
  • A positive test result for human immunodeficiency virus, or have a history of immunodeficiency.
  • A history of malignancy (including lymphoma and leukaemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localised carcinoma.
  • Had surgery within 90 days prior to Randomisation, and/or who plan to have an operation during the study period.
  • A history and/or current presence of an illness within 14 days prior to Randomisation that is classified as clinically significant.
  • Have a history of and/or current Coronavirus Disease-19 (COVID-19) defined as one of the following:
  • Positive test result for COVID-19 confirmed by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using real-time reverse transcriptase polymerase chain reaction (RT-PCR) at Day -1.
  • Signs and symptoms consistent with COVID-19 30 days prior to Randomisation.
  • Have had a positive test result for COVID-19 confirmed by SARS-CoV-2 detection using real-time RT-PCR.
  • Had severe course of COVID-19.
  • Smoked more than 10 cigarettes, 2 cigars or 2 pipes per day within 90 days prior to Screening.
  • Regular consumption of alcoholic beverages that exceeds 14 units.
  • A positive urinary drug screening result.
  • Any prescription medicine or over-the-counter medicines (except paracetamol) that might have an effect on the objectives of the study in the opinion of the Investigator, within 30 days prior to Randomisation.
  • Donated > 100 mL blood or plasma within 28 days prior to Randomisation.
  • Participated in another study with an investigational drug within 60 days prior to Randomisation or are currently participating in or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
  • Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
  • Subject who is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the clinical study.
  • Vulnerable subjects.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Parexel International GmbH, Early Phase Clinical Unit Berlin

    Berlin, 14050

Other trials in Germany

About this study

Official title: A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

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

Conditions
Healthy
Being tested
Adalimumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    SB5 (adalimumab), 40 mg, single-dose

Study groups in NCT04514796
Study groupRoleWhat they receive
40 mg/0.4 mL of SB5Experimental100 mg/mL of SB5
Receives: Drug: Adalimumab
40 mg/0.8 mL of SB5Active comparator50 mg/mL of SB5
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCinf

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

    Measured: Day 1 to Day 57

  2. Cmax

    Maximum serum concentration

    Measured: Day 1 to Day 57

Secondary outcomes (11)

  1. AUClast

    Area under the concentration-time curve from time zero to the last quantifiable concentration

    Measured: Day 1 to Day 57

  2. Tmax

    Time to reach Cmax

    Measured: Day 1 to Day 57

  3. Vz/F

    Apparent volume of distribution during the terminal phase

    Measured: Day 1 to Day 57

  4. λz

    Terminal rate constant

    Measured: Day 1 to Day 57

  5. t1/2

    Terminal half-life

    Measured: Day 1 to Day 57

  6. CL/F

    Apparent total body clearance

    Measured: Day 1 to Day 57

  7. %AUCextrap

    Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity

    Measured: Day 1 to Day 57

  8. Incidence of treatment-emergent adverse events (TEAEs)

    Experience at least 1 TEAE

    Measured: Day 1 to Day 57

  9. Incidence of serious adverse events (SAEs)

    Experience at least 1 SAE

    Measured: Day 1 to Day 57

  10. Incidence of anti-drug antibodies (ADAs)

    Incidence of ADAs to adalimumab

    Measured: Day 1 to Day 57

  11. Incidence of neutralising antibodies (NAbs)

    Incidence of NAbs to adalimumab

    Measured: Day 1 to Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start13 Aug 2020
  3. Primary completion15 May 2021
  4. Study completion15 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514796
Sponsor's protocol ID
SB5-1003
Status last verified
May 2021
First submitted
13 Aug 2020
Last updated
26 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35776269

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Adalimumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCinf (time frame: Day 1 to Day 57). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514796, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.

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