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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-04-17

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Bmab 1000

60mg/ml Prefilled syringe single dose

BIOLOGICAL

Prolia®

60mg/ml Prefilled syringe single dose

Sponsors & Collaborators

  • Biotrial

    collaborator INDUSTRY

  • Biocon Biologics UK Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-10-06
Completion
2023-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323708 on ClinicalTrials.gov