At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 146 enrolled
Drug / intervention
Denosumab CP4 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Denosumab CP4 and Denosumab CP2 for Healthy Volunteer. Completed, enrolled 146 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedFeb 2014
Primary CompletionAug 2014
TodayJul 2026
First PostedFeb 4, 2014
Enrollment StartFeb 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.4 years ago
Interventions
Denosumab CP4drug
Denosumab produced by a process referred to as CP4, administered subcutaneously.
Denosumab CP2drug
Denosumab produced by a process referred to as CP2, administered subcutaneously.