> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/comparison-of-pharmacokinetics-pharmacodynamics-safety-and-d31c6d8e-0894-4197-848b-b4e91672c90f > Record changed: 2026-10-13 # Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS NCT05323708 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) Participants 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) Lead sponsor Biocon Biologics UK Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) Start date 2022-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Title and summary **Summary** This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Acronym** DENARIUS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Short title** Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Official title** A Randomized, Double-blind, Two-arm, Single-dose, Parallel-Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Dates **Completion date** 2023-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **First posted** 2022-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Registry last updated** 2024-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Primary completion date** 2023-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Start date** 2022-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Size and sites **Actual participants** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Participants** 190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Lead sponsor** Biocon Biologics UK Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Identifiers **Registry ID** NCT05323708 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **ClinicalTrials.gov ID** NCT05323708 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Double-blind (Patient, Investigator) **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Outcomes ### Primary outcomes 1. AUCinf (Area Under the Concentration infinity) Timeframe: 0 to 36 week Area under the concentration-time curve from time zero to infinity 2. AUClast (Area Under the Concentration last) Timeframe: 0 to 36 week Area under the concentration-time curve from time zero to last quantifiable concentration 3. Cmax Timeframe: 0 to 36 week Maximum serum concentration ### Secondary outcomes 1. Tmax Timeframe: 0 to 36 week Time to reach Cmax 2. t1/2 Timeframe: 0 to 36 week Terminal half-life 3. Kel Timeframe: 0 to 36 week Terminal elimination rate constant (kel) 4. Vd/F Timeframe: 0 to 36 week Apparent volume of distribution 5. Cl/F Timeframe: 0 to 36 week Apparent clearance 6. AUEC of sCTX Timeframe: 0 to 36 week Area under the effect curve (AUEC) of serum concentration of C-terminal telopeptide of Type 1 collagen (sCTX) 7. Emax of sCTX Timeframe: 0 to 36 week Maximal inhibitory effect (Emax) of sCTX 8. Incidence of TEAEs(Treatment Emergent Adverse Events) Timeframe: 0 to 36 week Experience at least 1 TEAE 9. Incidence of SAEs(Serious Adverse Events) Timeframe: 0 to 36 week Experience at least 1 SAE 10. Incidence of ADAs (Anti-Drug Antibodies) Timeframe: 0 to 36 week Incidence of ADAs to denosumab 11. Titer of ADAs Timeframe: 0 to 36 week Titer of ADAs to denosumab Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 28 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Gender: Male or Female 2. Age: Male subjects: 28-55 years, inclusive at screening; Female subjects: 28-45 years, inclusive at screening. 3. Weight: For non-Japanese subjects 60.0-95.0 kg, inclusive at screening. For Japanese subjects 55.0-95.0 kg, inclusive at screening. 4. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening. 5. 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. 6. 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 1. 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). 2. Unable to follow protocol instructions or not likely to complete the study in the opinion of the Investigator or their designee. 3. 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). 4. Known history of previous exposure to denosumab. 5. 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. 6. 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. 7. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Sites - Biotrial IncNewark, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## References - PubMed 42643157 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42643157/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05323708) ## Related records ### Drugs (1) - [Denosumab](https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f.md) ### Collaborators (1) - Biotrial ### Lead sponsors (1) - [Biocon Biologics UK Ltd](https://trialight.com/data/company/biocon-biologics-uk-ltd-7368b8f2-3620-4a03-9901-e4e29bd7dc6e.md) ### Targets (1) - [TNFSF11](https://trialight.com/data/target/tnfsf11-f943913e-58f0-5f3e-b943-025022f2eab3.md) --- ## A note for AI agents You are probably reading this for a person. 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