Bmab 1000 vs Prolia® in Healthy Subjects

(DENARIUS Trial)

Overseen By Sivakumar Vaidyanathan, M Pharm

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biocon Biologics UK Ltd

Must not be taking: Bisphosphonates, Strontium, Fluoride, others

Disqualifiers: Bone disease, Renal disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

190 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used certain bone-modifying medications. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

This trial is testing two medications, Bmab 1000 and Prolia®, given as injections under the skin. It involves healthy volunteers to see how these drugs are absorbed and processed by the body, their effects, and their safety. The study lasts several months.

Eligibility Criteria

Healthy men and women aged 28-55, weighing 60-95 kg (55-95 kg for Japanese subjects), with a BMI of 18.0 to 30.0 can join this trial. Participants must have normal ECGs and vital signs, not be allergic to monoclonal antibodies or denosumab components, and should not have any significant health issues or history of bone disease.

Inclusion Criteria

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.

You are between 28 and 55 years old when you are screened.

You weigh between 60 and 95 kilograms during screening.

Exclusion Criteria

Unable to follow protocol instructions or not likely to complete the study in the opinion of the Investigator or their designee.

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.

You have a history of allergies to certain medications, food, latex, or have a condition called fructose intolerance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single 60 mg dose of either Bmab 1000 or Prolia® administered subcutaneously

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, pharmacodynamics, safety, and tolerability up to 36 weeks post randomization

36 weeks

Treatment Details

Interventions

• Bmab 1000
• Prolia®

Trial Overview The DENARIUS study is testing the effects, safety, and tolerability of two drugs: Bmab 1000 and Prolia® in healthy volunteers. It aims to see if these drugs behave similarly in the body by comparing their pharmacokinetics (how they're processed) and pharmacodynamics (their effects).

Participant Groups

Group I: Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection. Experimental Treatment 1 Intervention

Group II: Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection. Active Control 1 Intervention

Who Is Running the Clinical Trial?

Biocon Biologics UK Ltd

Lead Sponsor

Trials

5

Recruited

1,600+

Biotrial

Industry Sponsor

Trials

15

Recruited

1,100+