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NCT05323708 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study, sponsored by Biocon Biologics UK.
- Completed
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
NCT05323708: Completed Phase 1 study, sponsored by Biocon Biologics UK.
NCT05323708 is a Phase 1 study that has completed, run by Biocon Biologics UK. The registered enrollment target is 190 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05323708, a Phase 1 study, has completed, sponsored by Biocon Biologics UK.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
Study Summary
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
Primary Outcome
Area under the concentration-time curve from time zero to infinity
Interventions
- BIOLOGICAL Bmab 1000
- BIOLOGICAL Prolia®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2022-03-09 |
| Est. Completion | 2023-10-06 |
| Phase | Phase 1 |
What the finished NCT05323708 record still lists
NCT05323708 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher).
The record links to 0 conditions, and to 2 interventions - of which Bmab 1000 is the first listed.
NCT05323708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05323708 about?
NCT05323708 is a clinical study titled "Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS". This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
What is the current status of trial NCT05323708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2022-03-09. Estimated completion is 2023-10-06.
What interventions are being tested in trial NCT05323708?
The interventions under investigation include: Bmab 1000 (BIOLOGICAL), Prolia® (BIOLOGICAL).
Who is sponsoring clinical trial NCT05323708?
This trial is sponsored by Biocon Biologics UK, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05323708's enrollment target sits among peer trials
190 284th of 2000 higher than 1,713 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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