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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Biocon Biologics UK Ltd · Industry
• Sex: All
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

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 1:1 ratio to receive either Bmab 1000 or Prolia® on Day 1. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously. End-of-study visit will be at Week 36 post randomization. The total duration of study participation for a subject will be up to 40 weeks.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Bmab 1000	60mg/ml Prefilled syringe single dose
BIOLOGICAL	Prolia®	60mg/ml Prefilled syringe single dose

Timeline

• Start date: 2022-03-09
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2022-04-12
• Last updated: 2024-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study