Clinical trial
A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia®, and US-sourced Prolia®) in Healthy Adult Male Volunteers
NCT05245669 is registered in ClinicalTrials.gov with Enzene Biosciences Ltd. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia®, and US-sourced Prolia®) in Healthy Adult Male Volunteers
- Lead sponsor
- Enzene Biosciences Ltd.
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- January 10, 2022
- Completion date
- May 22, 2024
- Enrollment
- 207 (actual)
- Sites
- 2
Conditions
As the registry lists them; a condition with its own page is linked.
healthy male subjects