Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
NCT ID: NCT05245669
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
207 participants
INTERVENTIONAL
2022-01-10
2024-05-22
Brief Summary
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Detailed Description
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Each subject will be required to visit the site for a total of 20 visits: visit 1 - screening visit, visit 2 - day 0 to day 2, visit 3 - day 3, visit 4 - day 4, visit 5 - day 5, visit 6 - day 6, visit 7 - day 8, visit 8 - day 10, visit 9 - day 12, visit 10 - day 16, visit 11 - day 21, visit 12 - day 28 (week 4), visit 13 - day 42 (week 6), visit 14 - day 63 (week 9), visit 15 - day 90 (week 13), visit 16 - day 119 (week 17), visit 17 - day 147 (week 21), visit 18 - day 180 (week 26), visit 19 day - 224 (week 32), and visit 20 - day 270 (week 39). A window period of ±1 day is allowed for visit 12 (day 28), window period of ±3 days are allowed from day 42 (week 6) to day 180 (week 26), A window period of ±5 days are allowed from day 224 (week 32) to day 270 (week 39).
End of Study Assessment will be performed on day 270 (week 39) or at the time of early discontinuation of the subject.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ENZ215
ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1.
ENZ215
healthy volunteers receive ENZ215 (60mg) once
EU Sourced Prolia
EU sourced Prolia Injection:- 60 mg Denosumab (EU sourced Prolia) will be administered subcutaneously on day 1.
EU Sourced Prolia
healthy volunteers receive Denosumab (60mg) once
US Sourced Prolia
US sourced Prolia Injection:- 60 mg Denosumab (US sourced Prolia) will be administered subcutaneously on day 1.
US Sourced Prolia
healthy volunteers receive Denosumab (60mg) once
Interventions
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ENZ215
healthy volunteers receive ENZ215 (60mg) once
EU Sourced Prolia
healthy volunteers receive Denosumab (60mg) once
US Sourced Prolia
healthy volunteers receive Denosumab (60mg) once
Eligibility Criteria
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Inclusion Criteria
1. Able to understand and give written, voluntary informed consent for the study
2. Healthy adult male volunteers between 28 to 55 years of age (both inclusive)
3. Body Mass Index (BMI) ≥ 18.50 and ≤ 30.00 kg/m2 at the time of screening
4. Medically healthy with no clinically significant medical history, vital signs, physical examination, and laboratory profiles
5. Normal or clinically acceptable 12-lead electrocardiogram, QT interval corrected for heart rate (QTc interval)\* ≤ 450 msec at the time of screening
6. Subjects with negative alcohol test (breath analyzer or any suitable test) at the time of screening and admission (pre-dose)
7. Male subjects with female partners who agree to use effective contraception during study#
8. Male subjects who agree not to donate sperm during study
9. Willing and able to comply with the protocol requirements
10. Willing for multiple sampling and admission at the phase 1 study site day before dosing.
* Note: QTc interval will be calculated using the Bazette and Fridericia formula.
* Effective contraception: A non-vasectomised Male volunteers with female partners of child bearing potential should use dual method of contraception i.e. condom with spermicide method of contraception.
Female partners should use hormonal or non-hormonal method of contraception. (No restrictions are required for a vasectomised male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomised less than 4 months prior to the first dosing must follow the same restrictions as a non-vasectomised male).
Exclusion Criteria
1. Known hypersensitivity to Denosumab or to any of the components of the study drug
2. Participating or has received any investigational drug (or is currently using an investigational device) within 30 days before receiving the study drug, or at least 10 times the respective elimination halflife (whichever period is longer) \*
3. A serious infection (associated with housing and/or required intravenous anti-infectives) within 6 months before study drug administration and/or any active infection within 4 weeks of screening requiring oral or systemic antibiotics
4. History of significant drug abuse within 12 months before screening or a use of soft drugs (such as marijuana) within 3 months before the screening visit or hard drugs (such as cocaine, phencyclidine, and crack etc.) within 12 months before screening
5. Smokers who smoke ≥ 10 cigarettes or equivalent per day within 90 days prior to screening
6. Subjects with positive urine screen for drugs of abuse at the time of screening or check-in
7. Subjects with Urine Cotinine \> 500ng/ml at the time of screening or check-in
8. Subjects with risk of osteonecrosis of the jaw i.e. poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease or have undergone invasive dental procedures e.g. tooth extractions within last 6 months prior to screening.
9. Subjects with a predictable risk of invasive dental surgery during the 9 months after dosing or with planned invasive dental procedure
10. Subjects with known bone disease or recent fracture or abnormalities of calcium metabolism
11. Loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days before dosing
12. History of immunodeficiency (including those subjects with a positive test for human immunodeficiency virus \[HIV\] at screening)
13. Have a positive result for hepatitis B antigen test (HBsAg) or hepatitis C antibody test (HCAb), or show evidence of possible infection
14. Major surgical procedure within 28 days of dose of investigational product.
15. Male subjects having pregnant female partner at the time of screening.
16. Subject with a history of recurrent or chronic infections
17. Received live vaccines within 4 weeks or who may require live vaccine(s) during the study duration
18. Prior use of denosumab
19. 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.
20. Any reason/condition which would preclude subject's participation in the study as per the Investigator's opinion or warnings and contraindications in the prescribing information of Prolia
21. Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19).
28 Years
55 Years
MALE
Yes
Sponsors
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Alkem Laboratories Ltd
INDUSTRY
Enzene Biosciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Nadine Abdullah
Role: PRINCIPAL_INVESTIGATOR
Celerion GB Ltd.
Locations
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MC Comac Medical
Sofia, Sofia City Province, Bulgaria
MTZ Clinical Research powered by Pratia, Pratia S.A
Warsaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-004177-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALK22/ENZ215-DEN1
Identifier Type: -
Identifier Source: org_study_id