> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-compare-the-pharmacokinetics-pharmacodynamics-ebb235ae-6f33-44fd-b9f9-cbfcee214798 > Record changed: 2026-10-13 # Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers NCT05245669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) Participants 207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) Lead sponsor Enzene Biosciences Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) Start date 2022-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Title and summary **Summary** This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male volunteers. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Short title** Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Official title** A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia®, and US-sourced Prolia®) in Healthy Adult Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Dates **Completion date** 2024-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **First posted** 2022-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Registry last updated** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Primary completion date** 2024-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Start date** 2022-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Size and sites **Actual participants** 207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Participants** 207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Lead sponsor** Enzene Biosciences Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Identifiers **Registry ID** NCT05245669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **ClinicalTrials.gov ID** NCT05245669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Outcomes ### Primary outcomes 1. Maximum Observed Drug Concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia® Timeframe: 270 days A total of twenty four blood PK samples of 2.5 mL each were collected from each subject in the study. Pre-dose sample were collected within 30 minutes prior to IP administration. Post-dose samples up to Day 2 were collected within ± 10 minutes, within ± 2 hours from Day 3 to Day 21, within ± 1 day on Day 28, within ± 3 days from Day 42 to Day 180 and within ±5 days from Day 224 to Day 270\. Serum concentrations of denosumab were measured at central laboratory by a validated analytical method. 2. Area Under the Drug Concentration-time Curve From Day 0 to Day 270 (AUC0-t) of ENZ215, EU- and US-sourced Prolia®. and EU- and US-sourced Prolia® Timeframe: 270 days A total of twenty four blood PK samples of 2.5 mL each were collected from each subject in the study. Pre-dose sample were collected within 30 minutes prior to IP administration. Post-dose samples up to Day 2 were collected within ± 10 minutes, within ± 2 hours from Day 3 to Day 21, within ± 1 day on Day 28, within ± 3 days from Day 42 to Day 180 and within ±5 days from Day 224 to Day 270\. Serum concentrations of denosumab were measured at central laboratory by a validated analytical method. 3. Area Under the Drug Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of ENZ215, EU- and US-sourced Prolia®. and EU- and US-sourced Prolia® Timeframe: 270 days A total of twenty four blood PK samples of 2.5 mL each were collected from each subject in the study. Pre-dose sample were collected within 30 minutes prior to IP administration. Post-dose samples up to Day 2 were collected within ± 10 minutes, within ± 2 hours from Day 3 to Day 21, within ± 1 day on Day 28, within ± 3 days from Day 42 to Day 180 and within ±5 days from Day 224 to Day 270\. Serum concentrations of denosumab were measured at central laboratory by a validated analytical method. ### Secondary outcomes 1. Partial Area Under the Drug Concentration-time Curve From Time 0 (Pre-dose) to Day 28 Timeframe: 28 days AUC0-28 days were compared between ENZ215 and Prolia® using tests after log-transformation wherever appropriate. 2. Time to Reach Cmax (Tmax) Timeframe: 270 days The non-parametric analysis was used for the comparison of tmax between ENZ215 and Prolia®. 3. Terminal Elimination Half-life (t1/2) Timeframe: 270 days t1/2 was compared between ENZ215 and Prolia® using tests after log-transformation wherever appropriate. 4. Apparent Systemic Clearance (CL/F) Timeframe: 270 days CL/F was compared between ENZ215 and Prolia® using tests after log-transformation wherever appropriate. 5. Area Under the Effect Curve (AUEC) From Time 0 to Day 270 for Serum CTX-1 Percent Inhibition Percent Inhibition Timeframe: 270 days The AUEC was calculated as the area under the effect curve from baseline until CTX-1 values return to baseline for the first time. A total of sixteen (16) blood samples for serum CTX-1 estimation of 3.5 mL each was collected from each subject in the study. For CTX-1, blood samples were collected at the same time and after a minimum of 10 hours of fasting. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 28 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria The subjects will be included in the study based on the following 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 The subjects will be excluded from the study based on the following 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) \* \* For monoclonal antibody refer exclusion criteria number 18 and 19 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Sites - MC Comac MedicalSofia, Bulgaria - MTZ Clinical Research powered by Pratia, Pratia S.AWarsaw, Poland Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## References ### Other registry identifiers - 2021-004177-32 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05245669) ## Related records ### Drugs (2) - [Denosumab](https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f.md) - [Ustekinumab](https://trialight.com/data/asset/ustekinumab-323cb2e2-e906-4997-ac57-d82c7f7c399d.md) ### Collaborators (1) - Alkem Laboratories Ltd ### Lead sponsors (1) - [Enzene Biosciences Ltd.](https://trialight.com/data/company/enzene-biosciences-ltd-094d6933-0418-4eec-a2ff-13e11d0b7ac5.md) ### Targets (4) - [IL12A](https://trialight.com/data/target/il12a-f7e63dfd-cd53-5ed7-ab6b-30bc302a7278.md) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) - [TNFSF11](https://trialight.com/data/target/tnfsf11-f943913e-58f0-5f3e-b943-025022f2eab3.md) --- ## A note for AI agents You are probably reading this for a person. 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