CompletedPhase 1ACTRN12623000520639

A Study to Compare the Pharmacokinetic, Pharmacodynamics, safety, Tolerability and Immunogenicity of BP16 versus Prolia (US and EU approved) in Healthy male Volunteers.

Sponsor

CuraTeQ Biologics Private Ltd.

Enrollment

204 participants

Start Date

Jun 26, 2023

Study Type

Interventional

Conditions

Osteoporosis

Summary

A Randomized, Double-Blind, Parallel group, Comparative Phase I study for the assessment of Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers This is a phase 1 , multi centre randomized double blinded clinical trial in healthy male volunteers Primary objective is to assess the Pharmacokinetic similarity and to establish the Bioequivalence between the BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers Secondary objective is to assess the Pharmacodynamic similarity , to monitor the safety ,tolerability and to assess the immunogenicity between the BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers 204 Subjects will be enrolled and randomized in 1:1:1 ratio to receive the single dose subcutaneous injection of BP16/EU Prolia /US Prolia .

Eligibility

Sex: MalesMin Age: 28 YearssMax Age: 55 Yearss

Inclusion Criteria7

Each subject must meet all of the following criteria to be randomized in the study.
Male healthy volunteers of age 28-55 years (Inclusive of both) at the time of signing informed consent.
Body weight of 60 to 100 kg (both inclusive) and BMI of 18.5 to 30 kg/m2 (both inclusive) at screening visit and day -1 visit.
Subjects must understand the nature, purpose of the study including possible risks and side effects, agreed to participate in the study and is willing to sign the informed consent form before any study specific procedures.
Subjects are able to understand and comply with protocol requirements and instructions.
Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, pulse rate, body temperature, including respiratory rate) as judged by the Investigator at screening and day -1 visit.
Non-smokers or casual smokers who smoke no more than 5 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking 48 hours prior to day -1.

Exclusion Criteria13

Known history or presence of hypersensitivity to the active substance (Denosumab) or to any of the other excipients of investigational products.
History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.
Abnormal and clinically relevant (in the opinion of the Investigator) vital signs, ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
History of and/or current illness within 28 days prior to the study drug administration that is identified as clinically significant by the investigator.
Major surgery or major trauma within past six months of screening or anticipated need for any surgery during the study duration.
History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 21 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
Subject with evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate informed consent or limit the ability of the subject to comply with the protocol requirements in the opinion of the investigator.
Subjects with positive drug test at screening or admission.
Blood donation within 90 days or platelet/plasma donation within 14 days prior to dosing and during the study.
Difficulty in blood sampling or difficulty in accessibility of veins.
A serious infection (associated with housing and/or required intravenous anti-infectives) within 6 months before study drug administration and/or any active infection within 4 weeks of screening requiring oral or systemic antibiotics.
Subject is not likely to complete the study for whatever reason in the opinion of the investigator.

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Interventions

Participant will be randomly assigned to one of three arms in a 1:1:1 ratio to receive single dose (60mg/mL) of either BP16 or EU-Prolia® (EU sourced Denosumab) or US-Prolia® (US sourced Denosumab)

Participant will be randomly assigned to one of three arms in a 1:1:1 ratio to receive single dose (60mg/mL) of either BP16 or EU-Prolia® (EU sourced Denosumab) or US-Prolia® (US sourced Denosumab) Any information related to the participant is recorded across the source documentation and signed off by the appropriate staff member who performs specific inpatient duties and protocol-required tasks. The source records the time and the staff member who performed the duties for audit purposes.