Healthy Male SubjectsPhase 1NCT05245669
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
A Phase 1 study testing ENZ215, EU Sourced Prolia and US Sourced Prolia in people with Healthy Male Subjects, run by Enzene Biosciences Ltd. at 2 sites in 2 countries.
Trial 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. 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 Male Subjects
- What is being tested?
- ENZ215, EU Sourced Prolia and US Sourced Prolia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jan 2022to 22 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The subjects will be included in the study based on the following criteria:
- Able to understand and give written, voluntary informed consent for the study
- Healthy adult male volunteers between 28 to 55 years of age (both inclusive)
- Body Mass Index (BMI) ≥ 18.50 and ≤ 30.00 kg/m2 at the time of screening
- Medically healthy with no clinically significant medical history, vital signs, physical examination, and laboratory profiles
- Normal or clinically acceptable 12-lead electrocardiogram, QT interval corrected for heart rate (QTc interval)* ≤ 450 msec at the time of screening
Show all 14Show fewer
- Subjects with negative alcohol test (breath analyzer or any suitable test) at the time of screening and admission (pre-dose)
- Male subjects with female partners who agree to use effective contraception during study#
- Male subjects who agree not to donate sperm during study
- Willing and able to comply with the protocol requirements
- 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).
Who cannot join
- The subjects will be excluded from the study based on the following criteria:
- Known hypersensitivity to Denosumab or to any of the components of the study drug
- 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
- 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
- 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
Show all 23Show fewer
- Smokers who smoke ≥ 10 cigarettes or equivalent per day within 90 days prior to screening
- Subjects with positive urine screen for drugs of abuse at the time of screening or check-in
- Subjects with Urine Cotinine > 500ng/ml at the time of screening or check-in
- 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.
- Subjects with a predictable risk of invasive dental surgery during the 9 months after dosing or with planned invasive dental procedure
- Subjects with known bone disease or recent fracture or abnormalities of calcium metabolism
- 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
- History of immunodeficiency (including those subjects with a positive test for human immunodeficiency virus [HIV] at screening)
- Have a positive result for hepatitis B antigen test (HBsAg) or hepatitis C antibody test (HCAb), or show evidence of possible infection
- Major surgical procedure within 28 days of dose of investigational product.
- Male subjects having pregnant female partner at the time of screening.
- Subject with a history of recurrent or chronic infections
- Received live vaccines within 4 weeks or who may require live vaccine(s) during the study duration
- Prior use of denosumab
- 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.
- 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
- Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site
MTZ Clinical Research powered by Pratia, Pratia S.A
Warsaw, 02-172
About this study
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
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.
Read the detailed description
Approximately 207 subjects will be enrolled into 3 groups (69 in each group) in parallel. The subjects may be enrolled in multiple groups at the site. All eligible subjects will be assigned to one of the three treatment groups in 1:1:1 ratio i.e. ENZ215 or US-sourced Prolia® or EU-sourced Prolia® to enter into the study period of 39 weeks. The study duration will be approximately 16 months (i.e. 6 months of recruitment period, 4 weeks of screening period and approximately 39 weeks (270 days) of study period).
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
- Healthy Male Subjects
- Being tested
- ENZ215, EU Sourced Prolia, US Sourced Prolia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENZ215Biological
healthy volunteers receive ENZ215 (60mg) once
EU Sourced ProliaBiological
healthy volunteers receive Denosumab (60mg) once
US Sourced ProliaBiological
healthy volunteers receive Denosumab (60mg) once
| Study group | Role | What they receive |
|---|---|---|
| ENZ215 | Experimental | ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1. Receives: Biological: ENZ215 |
| EU Sourced Prolia | Active comparator | EU sourced Prolia Injection:- 60 mg Denosumab (EU sourced Prolia) will be administered subcutaneously on day 1. Receives: Biological: EU Sourced Prolia |
| US Sourced Prolia | Active comparator | US sourced Prolia Injection:- 60 mg Denosumab (US sourced Prolia) will be administered subcutaneously on day 1. Receives: Biological: US Sourced Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Drug Concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia®
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.
Measured: 270 days
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®
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.
Measured: 270 days
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®
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.
Measured: 270 days
Secondary outcomes (5)
Partial Area Under the Drug Concentration-time Curve From Time 0 (Pre-dose) to Day 28
AUC0-28 days were compared between ENZ215 and Prolia® using tests after log-transformation wherever appropriate.
Measured: 28 days
Time to Reach Cmax (Tmax)
The non-parametric analysis was used for the comparison of tmax between ENZ215 and Prolia®.
Measured: 270 days
Terminal Elimination Half-life (t1/2)
t1/2 was compared between ENZ215 and Prolia® using tests after log-transformation wherever appropriate.
Measured: 270 days
Apparent Systemic Clearance (CL/F)
CL/F was compared between ENZ215 and Prolia® using tests after log-transformation wherever appropriate.
Measured: 270 days
Area Under the Effect Curve (AUEC) From Time 0 to Day 270 for Serum CTX-1 Percent Inhibition Percent Inhibition
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.
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start10 Jan 2022
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: ENZ215 Arm 2 : EU Sourced Prolia Arm 3: US Sourced Prolia
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzene Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alkem Laboratories Ltd
- Responsible party
- Sponsor
- Investigators
- Dr. Nadine Abdullah, Principal investigator, Celerion GB Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245669
- Sponsor's protocol ID
- ALK22/ENZ215-DEN1
- Other IDs
- 2021-004177-32
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2022
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05245669
- Acronym / sponsor ID
- ALK22/ENZ215-DEN1
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Enzene Biosciences Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Alkem Laboratories Ltd
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 207 subjects will be enrolled into 3 groups (69 in each group) in parallel. The subjects may be enrolled in multiple groups at the site. All eligible subjects will be assigned to one of the three treatment groups in 1:1:1 ratio i.e. ENZ215 or US-sourced Prolia® or EU-sourced Prolia® to enter into the study period of 39 weeks. The study duration will be approximately 16 months (i.e. 6 months of recruitment period, 4 weeks of screening period and approximately 39 weeks (270 days) of study period).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Arm 1: ENZ215 Arm 2 : EU Sourced Prolia Arm 3: US Sourced Prolia
| Arm | Type | Receives |
|---|---|---|
| ENZ215 | Experimental | Biological: ENZ215ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1. |
| EU Sourced Prolia | Active comparator | Biological: EU Sourced ProliaEU sourced Prolia Injection:- 60 mg Denosumab (EU sourced Prolia) will be administered subcutaneously on day 1. |
| US Sourced Prolia | Active comparator | Biological: US Sourced ProliaUS sourced Prolia Injection:- 60 mg Denosumab (US sourced Prolia) will be administered subcutaneously on day 1. |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Able to understand and give written, voluntary informed consent for the study
- Healthy adult male volunteers between 28 to 55 years of age (both inclusive)
- Body Mass Index (BMI) ≥ 18.50 and ≤ 30.00 kg/m2 at the time of screening
- Medically healthy with no clinically significant medical history, vital signs, physical examination, and laboratory profiles
- Normal or clinically acceptable 12-lead electrocardiogram, QT interval corrected for heart rate (QTc interval)* ≤ 450 msec at the time of screening
Key exclusion criteria (23 listed)
- Known hypersensitivity to Denosumab or to any of the components of the study drug
- 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) *
- 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
- 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
- Smokers who smoke ≥ 10 cigarettes or equivalent per day within 90 days prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENZ215healthy volunteers receive ENZ215 (60mg) once | Biological | ENZ215 |
| EU Sourced Proliahealthy volunteers receive Denosumab (60mg) once | Biological | EU Sourced Prolia |
| US Sourced Proliahealthy volunteers receive Denosumab (60mg) once | Biological | US Sourced Prolia |
Primary outcome
Maximum Observed Drug Concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia®
Time frame: 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.
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®
Time frame: 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.
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®
Time frame: 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.
5 secondary outcomes
Partial Area Under the Drug Concentration-time Curve From Time 0 (Pre-dose) to Day 28
Time frame: 28 days
Time to Reach Cmax (Tmax)
Time frame: 270 days
Terminal Elimination Half-life (t1/2)
Time frame: 270 days
Apparent Systemic Clearance (CL/F)
Time frame: 270 days
Area Under the Effect Curve (AUEC) From Time 0 to Day 270 for Serum CTX-1 Percent Inhibition Percent Inhibition
Time frame: 270 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nadine Abdullah principal investigator
Celerion GB Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENZ215, EU Sourced Prolia and US Sourced Prolia in people with Healthy Male Subjects, run by Enzene Biosciences 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 14 inclusion and 23 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 23 Dec 2025. 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 Bulgaria, Poland. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Observed Drug Concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia® (time frame: 270 days). 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?
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 23 Dec 2025.