A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
A Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedSeptember 1, 2021
August 1, 2021
7 months
August 11, 2020
August 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate safety
safety in terms of treatment-emergent adverse events (TEAEs) of CT-P41 compared to that of EU-approved Prolia
through study completion, up to day 134
Study Arms (2)
CT-P41
EXPERIMENTAL60 mg/mL single dose administration, Solution for injection in PFS
EU-approved Prolia
ACTIVE COMPARATOR60 mg/mL single dose administration, Solution for injection in PFS
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects, between the ages of 28 and 55 years.
- Subject with a BMI between 18.5 and 29.9 kg/m2.
- Subject with albumin-adjusted total serum calcium ≥8.5 mg/dL (≥2.125 mol/L) and serum 25-OH vitamin D ≥20 ng/ml.
- Male subject and their female partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 5 months after the study drug administration.
You may not qualify if:
- Subject with a hypersensitivity to any component of denosumab.
- Subject has a history of and/or current known risk factors for hypocalcemia and osteonecrosis of jaw, and any clinically significant illness at investigator's discretion.
- Subject has a history of and/or concurrent use of medications such as an investigational drug, monoclonal antibody, fusion protein, and biologics.
- Subject has a history of and/or concurrent use of any therapy that might significantly affect bone metabolism.
- Subject is vulnerable.
- Subject is not likely to complete the study for whatever reason in the opinion of the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celltrionlead
Study Sites (1)
Q-Pharm Pty Ltd
Herston, Queensland, 4006, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 14, 2020
Study Start
October 20, 2020
Primary Completion
May 4, 2021
Study Completion
May 4, 2021
Last Updated
September 1, 2021
Record last verified: 2021-08