Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

  • STATUS
    Recruiting
  • End date
    May 14, 2023
  • participants needed
    207
  • sponsor
    Enzene Biosciences Ltd.
Updated on 14 April 2022
Accepts healthy volunteers

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.

Details
Condition Healthy Male Subjects
Treatment ENZ215, EU Sourced Prolia, US Sourced Prolia
Clinical Study IdentifierNCT05245669
SponsorEnzene Biosciences Ltd.
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

Inclusion 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 29.00 kg/m2 at the time of screening
Medically healthy with no clinically significant medical history, vital signs, physical examination, and laboratory profiles

Exclusion 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 half-life (whichever period is longer)
A serious infection (associated with housing and/or required intravenous antiinfectives) 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, crack etc.) within 12 months before screening
Subjects with positive urine screen for drugs of abuse at the time of screening or check-in
Subjects with positive urine screen for cotinine test at the time of screening or check-in
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
Any reason/ as per the warnings and contraindications in the prescribing information of Prolia
Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19) or with recent history (within 14 days) of travel/contact with any COVID-19 positive subject/isolation/quarantine
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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