Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (DENARIUS)
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
Sponsor: Biocon Biologics UK Ltd
A PHASE1 clinical study on Healthy Volunteers, this trial is completed. The trial is conducted by Biocon Biologics UK Ltd and has accumulated 5 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
May 2024 — Jul 2024 [monthly]
Completed PHASE1
Status: Active Not Recruiting → Completed
-
Jun 2023 — May 2024 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
-
May 2022 — Jun 2023 [monthly]
Recruiting PHASE1
First recorded
Mar 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Biocon Biologics UK Ltd
- Biotrial
For direct contact, visit the study record on ClinicalTrials.gov .