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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 is a Phase 1 study that has completed, run by Biocon Biologics UK. The registered enrollment target is 190 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05323708
The ClinicalTrials.gov registry entry for NCT05323708 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biocon Biologics UK, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bmab 1000 is the first listed.
NCT05323708 reports 0 study locations.
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.
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