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Monoclonal Antibodies

Bmab 1000 vs Prolia® in Healthy Subjects (DENARIUS Trial)

Phase 1
Waitlist Available
Research Sponsored by Biocon Biologics UK Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gender: Male
Age: 28-55 years, inclusive at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 36 week
Awards & highlights

DENARIUS Trial Summary

This trial is testing a new medication (Bmab 1000) to see how it compares to an existing medication (Prolia®) in terms of how it is processed by the body, how it affects the body, and how safe and tolerable it is.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
While specific side effects are not listed here as it's a study on healthy volunteers, typical side effects from such medications may include skin reactions at injection sites, low calcium levels in blood, infections like sinusitis or urinary tract infections.

DENARIUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be male.
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You are between 28 and 55 years old when you are screened.

DENARIUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 36 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 36 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUCinf (Area Under the Concentration infinity)
AUClast (Area Under the Concentration last)
Cmax
Secondary outcome measures
AUEC of sCTX
Cl/F
Emax of sCTX
+8 more

DENARIUS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection.Experimental Treatment1 Intervention
Group II: Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.Active Control1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Biocon Biologics UK LtdLead Sponsor
3 Previous Clinical Trials
1,246 Total Patients Enrolled
BiotrialIndustry Sponsor
10 Previous Clinical Trials
616 Total Patients Enrolled

Media Library

Bmab 1000 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05323708 — Phase 1
Healthy Subjects Research Study Groups: Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection., Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.
Healthy Subjects Clinical Trial 2023: Bmab 1000 Highlights & Side Effects. Trial Name: NCT05323708 — Phase 1
Bmab 1000 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05323708 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the anticipated outcome of this clinical investigation?

"The primary outcome to be measured by Biocon Biologics UK Ltd over a 0-36 week time frame will be AUCinf (Area Under the Concentration infinity). Additionally, they plan to assess secondary outcomes such as Emax of sCTX (Maximal inhibitory effect), Vd/F (Apparent volume of distribution), and Kel (Terminal elimination rate constant)."

Answered by AI

Is the enrollment period for this clinical trial still open?

"According to the listing on clinicaltrials.gov, recruitment for this trial is still taking place; it was initially posted on March 9th 2022 and most recently updated on April 12th of that same year."

Answered by AI

Who meets the criteria for participation in this clinical experiment?

"The recruitment criteria for this medical trial state that potential subjects must be aged between 28 and 55 years old. Additionally, they should possess a healthy constitution (hs). Altogether, 190 participants are being sought out."

Answered by AI

Is the enrollment window for this experiment open to individuals over 60 years of age?

"This trial is only open to applicants aged 28-55. Those below 18 years of age have 50 studies available while those above 65 are eligible for 373 different medical trials."

Answered by AI

Has Bmab 1000 been verified by the Food and Drug Administration?

"There is only minimal clinical data for the safety of Bmab 1000, so it has been given a rating of 1."

Answered by AI

What is the current size of the cohort for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this experimental trial is recruiting patients and was initially published on March 9th 2022 with its last edit occurring April 12th 2022. 190 participants are needed from one site for the project's completion."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
How old are they?
65+
What site did they apply to?
Biotrial Inc
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
2022. "Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05323708.
~62 spots leftby Apr 2025
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