NCT05323708View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

March 9, 2022

Primary Completion Date

October 6, 2023

Study Completion Date

October 6, 2023

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

Bmab 1000

60mg/ml Prefilled syringe single dose

BIOLOGICAL

Prolia®

60mg/ml Prefilled syringe single dose

Trial Locations (1)

07103

Biotrial Inc, Newark

Sponsors

Collaborators (1)

Biotrial
All Listed Sponsors
collaborator

Biotrial

INDUSTRY

lead

Biocon Biologics UK Ltd

INDUSTRY

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 | Biotech Hunter | Biotech Hunter