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NCT02053753COMPLETEDanonymous

A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

Sponsor

Source record

Amgen

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab CP4, Denosumab CP2

Indication / condition

AI-normalized

Healthy Volunteer

Intervention

Source record

Denosumab CP4, Denosumab CP2

Source & freshness

Source record

NCT ID

NCT02053753

Original source

ClinicalTrials.gov

Source last updated

Dec 29, 2017

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

NCT02053753

Title

A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

Sponsor

Amgen

Status

COMPLETED

Phase

PHASE1

Condition raw

Healthy Volunteer

Condition normalized

Healthy Volunteer

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Denosumab CP4, Denosumab CP2

Target normalized

Denosumab CP4, Denosumab CP2

Interventions

Denosumab CP4, Denosumab CP2

Public preview

Source record

To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.

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 Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

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

Generated

Jun 13, 2026

NCT ID

NCT02053753

Status

COMPLETED

Phase

PHASE1

Sponsor

Amgen

Executive brief

Investment-Ready Snapshot

To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedDec 29, 2017
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT02053753

Indication

Healthy Volunteer

Modality

monoclonal antibody

Target

Denosumab CP4, Denosumab CP2

Intervention

Denosumab CP4, Denosumab CP2

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.