AzTrials
AzTrials

HealthyPhase 1NCT04621318

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

A Phase 1 study testing Denosumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 2 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects. Read more about this study

Who is it for?
Ages 28 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Denosumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
2 sitesin 2 countries
Study dates
19 Oct 2020to 9 Nov 2022
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 28 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male, aged 28-55 years (inclusive) on the day of signing the informed consent.
  • Have a body weight between 60.0-90.0 kg (inclusive) and a BMI between 20.0-29.9 kg/m2 (inclusive).
  • Have 12-lead ECG results without clinically significant abnormal findings confirmed by the Investigator.
  • Have vital sign results without clinically significant abnormal findings confirmed by the Investigator.
  • Have physical examination results without clinically significant abnormal findings confirmed by the Investigator.
  • Male subjects who have not had 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 tubal ligation unless their partners are infertile (confirmed with written verifications) during the treatment period.
Show all 9Show fewer
  • Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
  • Able to provide written informed consent, which must be obtained prior to any study related procedures being performed.
  • Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

Who cannot join

  • Have a history and/or current presence of clinically significant atopic allergy, hypersensitivity, or allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to denosumab or to any of the excipients.
  • Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies.
  • Have a history of bone disease or any medical condition that can affect bone metabolism (including osteoporosis, osteogenesis imperfecta, osteomalacia, hyperparathyroidism, hyperthyroidism, hypothyroidism, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Paget's disease of the bone, and malabsorption syndrome).
  • Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
  • Have ONJ or risk factors for ONJ such as invasive dental procedures or active periodontal disease within 180 days prior to Randomisation.
  • Have bone fractures within 180 days prior to Randomisation.
Show all 32Show fewer
  • Have a history of serious infection (associated with hospitalisation and/or which required intravenous antibiotics) within 180 days prior to Randomisation.
  • Have a clinically significant active infection (bacterial, viral, or fungal) including skin infections within 28 days prior to Randomisation.
  • Have any systemic or local infection, a known risk for developing sepsis.
  • Have known intolerance to calcium or vitamin D supplements.
  • Have previously been exposed to denosumab (Prolia®/Xgeva®) and its biosimilar.
  • Have previously been exposed to a monoclonal antibody or fusion protein within 270 days (other than denosumab) prior to Randomisation and/or there is confirmed evidence or clinical suspicion 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 Randomisation.
  • Have received live vaccines(s) within 30 days prior to Randomisation or who will require live vaccine(s) during the study period.
  • Have a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
  • Have any of the following abnormal laboratory test results:
  • Albumin-adjusted serum calcium levels below the LLN or above the ULN.
  • Serum creatinine levels above 1.5 × ULN.
  • Any other laboratory abnormalities assessed as clinically significant by the Investigator.
  • Have a positive test result for HBsAg, HCV antibody, or HIV 1or 2.
  • Have a history of immunodeficiency.
  • Have had surgery within 90 days prior to Randomisation, and/or plan to have an operation (including invasive dental procedure) during the study period.
  • Have a history and/or current presence of an illness (including, but not limited to respiratory symptoms [e.g., difficulty breathing or persistent cough] or low-grade fever) within 14 days prior to Randomisation that is classified as clinically significant by the Investigator.
  • Have smoked more than 10 cigarettes, 2 cigars, or 2 pipes per day within 90 days prior to Screening.
  • Have regular consumption of alcoholic beverages that exceeds 14 units per week.
  • Have a positive urinary drug screening result or alcohol breath test result at Screening or Day -1.
  • Have taken 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 or 10 half-lives of the medication (whichever period is longer) prior to Randomisation. This includes medications such as, but not limited to: Bisphosphonates, parathyroid hormone, hormone replacement therapy, selective estrogen receptor modulators, calcitonin, calcitriol, glucocorticoids, fluoride, strontium, or anabolic steroids.
  • Have donated > 100 mL blood or plasma within 28 days prior to Randomisation.
  • Have 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 evaluation 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

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Biotrial

    Newark, New Jersey, 07103

Other trials in United States

France1 site

  • Biotrial Rennes

    Rennes

Other trials in France

About this study

Official title: A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects

This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

Conditions
Healthy
Being tested
Denosumab

What participants receive

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

  • DenosumabDrug

    60 mg, single-dose

Study groups in NCT04621318
Study groupRoleWhat they receive
SB16ExperimentalSB16 (proposed denosumab biosimilar)
Receives: Drug: Denosumab
EU ProliaActive comparatorEU sourced Prolia (denosumab)
Receives: Drug: Denosumab
US ProliaActive comparatorUS sourced Prolia (denosumab)
Receives: Drug: Denosumab

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 197

  2. AUClast

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

    Measured: Day 1 to Day 197

  3. Cmax

    Maximum serum concentration

    Measured: Day 1 to Day 197

Secondary outcomes (11)

  1. Tmax

    Time to reach Cmax

    Measured: Day 1 to Day 197

  2. Vz/F

    Apparent volume of distribution during the terminal phase

    Measured: Day 1 to Day 197

  3. λz

    Terminal rate constant

    Measured: Day 1 to Day 197

  4. t1/2

    Terminal half-life

    Measured: Day 1 to Day 197

  5. CL/F

    Apparent clearance

    Measured: Day 1 to Day 197

  6. %AUCextrap

    Percentage of AUCinf due to extrapolation from Tlast to infinity

    Measured: Day 1 to Day 197

  7. AUEC for CTX percent inhibition

    Area under the effect curve from time zero to Day 197 for serum CTX percent inhibition

    Measured: Day 1 to Day 197

  8. Incidence of TEAEs

    Experience at least 1 TEAE

    Measured: Day 1 to Day 197

  9. Incidence of SAEs

    Experience at least 1 SAE

    Measured: Day 1 to Day 197

  10. Incidence of ADAs

    Incidence of ADAs to denosumab

    Measured: Day 1 to Day 197

  11. Incidence of NAbs

    Incidence of NAbs to denosumab

    Measured: Day 1 to Day 197

Timeline

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

  1. First posted9 Nov 2020
  2. Study start19 Oct 2020
  3. Primary completion9 Nov 2022
  4. Study completion9 Nov 2022

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621318
Sponsor's protocol ID
SB16-1001
Status last verified
Nov 2022
First submitted
3 Nov 2020
Last updated
28 Nov 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lee HA, Kim S, Seo H, Kim S. A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects. Expert Opin Investig Drugs. 2023 Jul-Dec;32(10):959-966. doi: 10.1080/13543784.2023.2273510. Epub 2023 Nov 6.

    PubMed 37870163

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Denosumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 2 sites in 2 countries.

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 32 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 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, France. 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 197). The study lists 3 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 NCT04621318, 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 28 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in