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

B

Biocon

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Biological: Bmab 1000
Biological: Prolia®

Study type

Interventional

Funder types

Industry

Identifiers

NCT05323708
B1000-NHV-01-G-01

Details and patient eligibility

About

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

Full description

This study will consist of 2 study periods: Screening period (4 weeks) and Treatment period (Dosing and follow-up). In this double-blind, 2-arm study, the eligible subjects will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia® on Day 1. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously. End-of-study visit will be at Week 36 post randomization. The total duration of study participation for a subject will be up to 40 weeks.

Enrollment

190 patients

Sex

All

Ages

28 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Gender: Male or Female
  2. Age: Male subjects: 28-55 years, inclusive at screening; Female subjects: 28-45 years, inclusive at screening.
  3. Weight: For non-Japanese subjects 60.0-95.0 kg, inclusive at screening. For Japanese subjects 55.0-95.0 kg, inclusive at screening.
  4. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
  5. 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.
  6. 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator or their designee.

Exclusion criteria

  1. 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).
  2. Unable to follow protocol instructions or not likely to complete the study in the opinion of the Investigator or their designee.
  3. 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).
  4. Known history of previous exposure to denosumab.
  5. 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.
  6. 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.
  7. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

190 participants in 2 patient groups

Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection.
Experimental group
Treatment:
Biological: Bmab 1000
Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.
Active Comparator group
Treatment:
Biological: Prolia®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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