# Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

> **NCT05245669** · PHASE1 · COMPLETED · sponsor: **Enzene Biosciences Ltd.** · enrollment: 207 (actual)

## Conditions studied

- Healthy Male Subjects

## Interventions

- **BIOLOGICAL:** ENZ215
- **BIOLOGICAL:** EU Sourced Prolia
- **BIOLOGICAL:** US Sourced Prolia

## Key facts

- **NCT ID:** NCT05245669
- **Lead sponsor:** Enzene Biosciences Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-01-10
- **Primary completion:** 2024-05-22
- **Final completion:** 2024-05-22
- **Target enrollment:** 207 (ACTUAL)
- **Last updated:** 2025-12-23

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05245669

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05245669, "Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT05245669. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*