Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS

NCT05323708 | Completed Phase 1 FDA Drug

• 1 other identifier: B1000-NHV-01-G-01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• AUCinf (Area Under the Concentration infinity)

  Area under the concentration-time curve from time zero to infinity

  0 to 36 week

• AUClast (Area Under the Concentration last)

  Area under the concentration-time curve from time zero to last quantifiable concentration

  0 to 36 week

• Cmax

  Maximum serum concentration

  0 to 36 week

Secondary Outcomes (11)

• Tmax

  0 to 36 week

• t1/2

  0 to 36 week

• Kel

  0 to 36 week

• Vd/F

  0 to 36 week

• Cl/F

  0 to 36 week

Study Arms (2)

Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection.

EXPERIMENTAL

Biological: Bmab 1000

Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.

ACTIVE COMPARATOR

Biological: Prolia®

Interventions

Bmab 1000 BIOLOGICAL

60mg/ml Prefilled syringe single dose

Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection.

Prolia® BIOLOGICAL

60mg/ml Prefilled syringe single dose

Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender: Male or Female
• Age: Male subjects: 28-55 years, inclusive at screening; Female subjects: 28-45 years, inclusive at screening.
• Weight: For non-Japanese subjects 60.0-95.0 kg, inclusive at screening. For Japanese subjects 55.0-95.0 kg, inclusive at screening.
• Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
• Vital signs showing no clinically relevant deviations according to the Investigator's judgment or their designee's. In the case of subjects \> 45 year-old, if a value of SBP above 145 mmHg is confirmed on rechecking the BP after a period of rest, this subject will not be included in the study.
• lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator or their designee.

You may not qualify if:

• Evidence of clinically relevant pathology: Like have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies. Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
• Unable to follow protocol instructions or not likely to complete the study in the opinion of the Investigator or their designee.
• History of relevant drug and/or food allergies (including hypersensitivity to any recombinant protein drug or any of the constituents of denosumab, or latex allergy or hereditary problems of fructose intolerance).
• Known history of previous exposure to denosumab.
• Have previously been exposed to a monoclonal antibody or fusion protein (other than denosumab) within 270 days (or 5 half-lives whichever is the longest) prior to randomization and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
• Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfect, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as glomerular filtration rate \< 60 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome.
• Any use of the following bone modifying medications, with no limitation on time since administration: e.g.intravenous bisphosphonates, strontium, fluoride (if administered in treatment of osteoporosis),romosozumab, teriparatide or any parathyroid hormone analogs, calcitonin, and cinacalcet.

Sponsors & Collaborators

• Biocon Biologics UK Ltd: lead
• Biotrial: collaborator

Study Sites (1)

Biotrial Inc

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (Patient, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 12, 2022
• Study Start: March 9, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)