# A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

> **NCT06095427** · PHASE1 · COMPLETED · sponsor: **Luye Pharma Group Ltd.** · enrollment: 300 (actual)

## Conditions studied

- Healthy

## Interventions

- **BIOLOGICAL:** LY06006 (Denosumab Biosimilar)
- **BIOLOGICAL:** US-Prolia (Denosumab)
- **BIOLOGICAL:** EU-Prolia

## Key facts

- **NCT ID:** NCT06095427
- **Lead sponsor:** Luye Pharma Group Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-03-09
- **Primary completion:** 2023-03-14
- **Final completion:** 2023-03-14
- **Target enrollment:** 300 (ACTUAL)
- **Last updated:** 2023-10-23

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06095427

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06095427, "A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection". Retrieved via AI Analytics 2026-06-30 from https://api.ai-analytics.org/clinical/NCT06095427. Licensed CC0.

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