Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02053753 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
A Phase 1 study of Healthy Volunteer, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 2
- Study locations
NCT02053753: Completed Phase 1 study of Healthy Volunteer, sponsored by Amgen.
NCT02053753 is a Phase 1 study of Healthy Volunteer that has completed, run by Amgen. The registered enrollment target is 146 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (27% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02053753, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.
Conditions Studied
Interventions
- DRUG Denosumab CP4
- DRUG Denosumab CP2
Study Locations (2)
California
- Research Site - Cypress
Texas
- Research Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT02053753 record still lists
NCT02053753 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Denosumab CP4 is the first listed.
NCT02053753 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT02053753 about?
NCT02053753 is a clinical study titled "Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product". 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.
What is the current status of trial NCT02053753?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2014-02. Estimated completion is 2014-08.
What conditions does trial NCT02053753 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT02053753?
The interventions under investigation include: Denosumab CP4 (DRUG), Denosumab CP2 (DRUG).
Who is sponsoring clinical trial NCT02053753?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02053753 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02053753's enrollment target sits among peer trials
146 26th of 112 higher than 87 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Healthy Volunteer Study
RECRUITING · Phase 1
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
RECRUITING · Phase 1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
RECRUITING · Phase 1
-
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
RECRUITING · Phase 1
-
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03490929 · 146 participants · Phase 4
CEUS for Blunt Abdominal Trauma in Children
- NCT04755062 · 146 participants · NA
A Culturally-relevant Micronutrient-dense Plant-rich (mNDPR) Dietary Intervention for Native Americans
- NCT04867954 · 146 participants
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
- NCT05051618 · 146 participants · NA
Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia