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NCT05299073COMPLETEDanonymous

A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers

Sponsor

Source record

mAbxience Research S.L.

Phase

Source record

PHASE 1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab Biosimilar (MB09)

Indication / condition

AI-normalized

Healthy Volunteers

Intervention

Source record

MB09, US-sourced Xgeva, EU-sourced Xgeva

Source & freshness

Source record

NCT ID

NCT05299073

Original source

ClinicalTrials.gov

Source last updated

Jan 03, 2025

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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NCT ID

NCT05299073

Title

A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers

Sponsor

mAbxience Research S.L.

Status

COMPLETED

Phase

PHASE 1

Condition raw

Healthy Volunteers

Condition normalized

Healthy Volunteers

Modality raw

Healthy Volunteers

Modality normalized

monoclonal antibody

Target raw

Denosumab Biosimilar (MB09)

Target normalized

Denosumab Biosimilar (MB09)

Interventions

MB09, US-sourced Xgeva, EU-sourced Xgeva

Public preview

Source record

The clinical trial evaluated the pharmacokinetic (PK) similarity, pharmacodynamics (PD), safety, and immunogenicity of MB09, a biosimilar to Xgeva, in healthy male volunteers. The study was conducted by mAbxience Research S.L. and involved 257 participants across three arms: MB09, US-sourced Xgeva, and EU-sourced Xgeva.

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 Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers

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

Generated

Jun 13, 2026

NCT ID

NCT05299073

Status

COMPLETED

Phase

PHASE 1

Sponsor

mAbxience Research S.L.

Executive brief

Investment-Ready Snapshot

The clinical trial evaluated the pharmacokinetic (PK) similarity, pharmacodynamics (PD), safety, and immunogenicity of MB09, a biosimilar to Xgeva, in healthy male volunteers. The study was conducted by mAbxience Research S.L. and involved 257 participants across three arms: MB09, US-sourced Xgeva, and EU-sourced Xgeva.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJan 03, 2025
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05299073

Indication

Healthy Volunteers

Modality

monoclonal antibody

Target

Denosumab Biosimilar (MB09)

Intervention

MB09, US-sourced Xgeva, EU-sourced Xgeva

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.