drugset
drugset / Trial / NCT05323708

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 ↗

Phase 1 Completed 190 enrolled Biocon Biologics UK Ltd Biotrial Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2022-03-09
Primary completion
2023-10-06
Completion
2023-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bmab 1000 Unknown 60 mg Subcutaneous
Comparator Denosumab Monoclonal antibody 60 mg Subcutaneous

Indications

No indication recorded.