Status:
COMPLETED
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
Lead Sponsor:
Biocon Biologics UK Ltd
Collaborating Sponsors:
Biotrial
Conditions:
Healthy Volunteers
Eligibility:
All Genders
28-55 years
Phase:
PHASE1
Brief Summary
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
Detailed 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:...
Eligibility Criteria
Inclusion
- Gender: Male or Female
- Age: Male subjects: 28-55 years, inclusive at screening; Female subjects: 28-45 years, inclusive at screening.
- Weight: For non-Japanese subjects 60.0-95.0 kg, inclusive at screening. For Japanese subjects 55.0-95.0 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. In the case of subjects \> 45 year-old, if a value of SBP above 145 mmHg is confirmed on rechecking the BP after a period of rest, this subject will not be included in the study.
- 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
- 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 imperfect, 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05323708
Start Date
March 9 2022
End Date
October 6 2023
Last Update
April 17 2024
Active Locations (1)
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1
Biotrial Inc
Newark, New Jersey, United States, 07103