Status:
COMPLETED
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
Lead Sponsor:
Enzene Biosciences Ltd.
Collaborating Sponsors:
Alkem Laboratories Ltd
Conditions:
Healthy Male Subjects
Eligibility:
MALE
28-55 years
Phase:
PHASE1
Brief 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 subcutaneo...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- 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).
- EXCLUSION CRITERIA
- 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
- 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).
Exclusion
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT05245669
Start Date
January 10 2022
End Date
May 22 2024
Last Update
December 23 2025
Active Locations (2)
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1
MC Comac Medical
Sofia, Sofia City Province, Bulgaria, 1000
2
MTZ Clinical Research powered by Pratia, Pratia S.A
Warsaw, Poland, 02-172