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NCT05876949COMPLETEDanonymous

A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects

Sponsor

Source record

Alvotech Swiss AG

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

AVT03 (biosimilar to Denosumab)

Indication / condition

AI-normalized

This is a Phase I Study Conducted in Healthy Volunteers

Intervention

Source record

AVT03, Denosumab

Source & freshness

Source record

NCT ID

NCT05876949

Original source

ClinicalTrials.gov

Source last updated

May 15, 2025

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05876949

Title

A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects

Sponsor

Alvotech Swiss AG

Status

COMPLETED

Phase

PHASE1

Condition raw

This is a Phase I Study Conducted in Healthy Volunteers

Condition normalized

This is a Phase I Study Conducted in Healthy Volunteers

Modality raw

This is a Phase I Study Conducted in Healthy Volunteers

Modality normalized

monoclonal antibody

Target raw

AVT03 (biosimilar to Denosumab)

Target normalized

AVT03 (biosimilar to Denosumab)

Interventions

AVT03, Denosumab

Public preview

Source record

AVT03 is a proposed biosimilar to Xgeva (denosumab), developed by Alvotech Swiss AG. The clinical trial aimed to compare the pharmacokinetic, safety, and immunogenicity profiles of AVT03 against the reference product in healthy male subjects aged 28 to 55. The study was completed with a total enrollment of 208 participants.

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, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects

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

Generated

Jun 13, 2026

NCT ID

NCT05876949

Status

COMPLETED

Phase

PHASE1

Sponsor

Alvotech Swiss AG

Executive brief

Investment-Ready Snapshot

AVT03 is a proposed biosimilar to Xgeva (denosumab), developed by Alvotech Swiss AG. The clinical trial aimed to compare the pharmacokinetic, safety, and immunogenicity profiles of AVT03 against the reference product in healthy male subjects aged 28 to 55. The study was completed with a total enrollment of 208 participants.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMay 15, 2025
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05876949

Indication

This is a Phase I Study Conducted in Healthy Volunteers

Modality

monoclonal antibody

Target

AVT03 (biosimilar to Denosumab)

Intervention

AVT03, Denosumab

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.