Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
Study Details
Study Description
Brief Summary
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ENZ215 ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1. |
Biological: ENZ215
healthy volunteers receive ENZ215 (60mg) once
|
| Active Comparator: EU Sourced Prolia EU sourced Prolia Injection:- 60 mg Denosumab (EU sourced Prolia) will be administered subcutaneously on day 1. |
Biological: EU Sourced Prolia
healthy volunteers receive Denosumab (60mg) once
|
| Active Comparator: US Sourced Prolia US sourced Prolia Injection:- 60 mg Denosumab (US sourced Prolia) will be administered subcutaneously on day 1. |
Biological: US Sourced Prolia
healthy volunteers receive Denosumab (60mg) once
|
Outcome Measures
Primary Outcome Measures
- Maximum observed drug concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia® [270 days]
- Area under the drug concentration-time curve from day 0 to day 270 (AUC0-t) of ENZ215 and EU- and US-sourced Prolia® [270 days]
- Area under the drug concentration-time curve from time 0 to infinity (AUC0-inf) of ENZ215 and EU- and US-sourced Prolia® [270 days]
Secondary Outcome Measures
- Partial area under the drug concentration-time curve from time 0 (pre-dose) to day 28 [28 days]
- Time to reach Cmax (tmax) [270 days]
- Terminal elimination half-life (t1/2) [270 days]
- Apparent systemic clearance (CL/F) [270 days]
- Area under the effect curve (AUEC) from time 0 to Day 270 for serum CTX-1 percent inhibition [270 days]
Other Outcome Measures
- Number of subjects who developed denosumab neutralizing antibodies and antidrug antibodies [270 days]
- Incidence of adverse events [270 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to understand and give written, voluntary informed consent for the study
-
Healthy adult male volunteers between 28 to 55 years of age (both inclusive)
-
Body Mass Index (BMI) 18.50 and 29.00 kg/m2 at the time of screening
-
Medically healthy with no clinically significant medical history, vital signs, physical examination, and laboratory profiles
Exclusion Criteria:
-
Known hypersensitivity to Denosumab or to any of the components of the study drug
-
Participating or has received any investigational drug (or is currently using an investigational device) within 30 days before receiving the study drug, or at least 10 times the respective elimination half-life (whichever period is longer)
-
A serious infection (associated with housing and/or required intravenous antiinfectives) within 6 months before study drug administration and/or any active infection within 4 weeks of screening requiring oral or systemic antibiotics
-
History of significant drug abuse within 12 months before screening or a use of soft drugs (such as marijuana) within 3 months before the screening visit or hard drugs (such as cocaine, phencyclidine, crack etc.) within 12 months before screening
-
Subjects with positive urine screen for drugs of abuse at the time of screening or check-in
-
Subjects with positive urine screen for cotinine test at the time of screening or check-in
-
Have a positive result for hepatitis B antigen test (HBsAg) or hepatitis C antibody test (HCAb), or show evidence of possible infection
-
Major surgical procedure within 28 days of dose of investigational product
-
Any reason/ as per the warnings and contraindications in the prescribing information of Prolia
-
Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus infection (COVID-19) or with recent history (within 14 days) of travel/contact with any COVID-19 positive subject/isolation/quarantine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Celerion GB Ltd. | Belfast | United Kingdom | BT9 6AD |
Sponsors and Collaborators
- Enzene Biosciences Ltd.
- Alkem Laboratories Ltd
Investigators
- Principal Investigator: Dr. Nadine Abdullah, Celerion GB Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALK22/ENZ215-DEN1