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

Related intelligence directories

Indication directory: This is a Phase I Study Conducted in Healthy Volunteers Modality directory: monoclonal antibody Target directory: AVT03 (biosimilar to 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 20, 2026

NCT ID

NCT05876949

Status

COMPLETED

Phase

PHASE1

Sponsor

Alvotech Swiss AG

Executive brief

Investment-Ready Snapshot

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