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NCT06095427COMPLETEDanonymous

A Randomized, Double Blind, Three-Arm, Parallel Group, 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

Sponsor

Source record

Luye Pharma Group Ltd.

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Indication / condition

AI-normalized

Healthy

Intervention

Source record

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Source & freshness

Source record

NCT ID

NCT06095427

Original source

ClinicalTrials.gov

Source last updated

Oct 23, 2023

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT06095427

Title

A Randomized, Double Blind, Three-Arm, Parallel Group, 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

Sponsor

Luye Pharma Group Ltd.

Status

COMPLETED

Phase

PHASE1

Condition raw

Healthy

Condition normalized

Healthy

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Target normalized

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Interventions

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Public preview

Source record

This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and then be followed for 36 weeks.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Randomized, Double Blind, Three-Arm, Parallel Group, 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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT06095427

Status

COMPLETED

Phase

PHASE1

Sponsor

Luye Pharma Group Ltd.

Executive brief

Investment-Ready Snapshot

This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and then be followed for 36 weeks.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 23, 2023
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06095427

Indication

Healthy

Modality

monoclonal antibody

Target

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Intervention

LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.