Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Male Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (DENARIUS)

  • STATUS
    Recruiting
  • End date
    Feb 6, 2024
  • participants needed
    190
  • sponsor
    Biocon Biologics UK Ltd
Updated on 30 April 2022
Accepts healthy volunteers

Summary

This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy adult male volunteers.

Description

This study will consist of 2 study periods: Screening period (4 weeks) and Treatment period (Dosing and follow-up).

In this double-blind, 2-arm study, the eligible subjects will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia® on Day 1. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously. End-of-study visit will be at Week 36 post randomization.

The total duration of study participation for a subject will be up to 40 weeks.

Details
Condition Healthy Volunteers
Treatment Prolia®, Bmab 1000
Clinical Study IdentifierNCT05323708
SponsorBiocon Biologics UK Ltd
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male
Age: 28-55 years, inclusive at screening
Weight: 60.0-95.0 kg, inclusive at screening
Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening
Vital signs showing no clinically relevant deviations according to the Investigator's judgment, or their designee's
12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator or their designee

Exclusion Criteria

Evidence of clinically relevant pathology: Like have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies. Have a history of malignancy (including lymphoma, leukaemia, and skin cancer)
Unable to follow protocol instructions or not likely to complete the study in the opinion of the Investigator or their designee
History of relevant drug and/or food allergies (including hypersensitivity to any recombinant protein drug or any of the constituents of denosumab, or latex allergy or hereditary problems of fructose intolerance)
Known history of previous exposure to denosumab
Have previously been exposed to a monoclonal antibody or fusion protein (other than denosumab) within 270 days (or 5 half-lives whichever is the longest) prior to randomization and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein
Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as glomerular filtration rate < 60 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome
Any use of the following bone modifying medications, with no limitation on time since administration: e.g.intravenous bisphosphonates, strontium, fluoride (if administered in treatment of osteoporosis),romosozumab, teriparatide or any parathyroid hormone analogs, calcitonin, and cinacalcet
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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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