Bmab 1000 for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsBmab 1000 - Biological
Eligibility
28 - 55
Male
What conditions do you have?
Select

Study 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.

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: 0 to 36 week

0 to 36 week
AUCinf (Area Under the Concentration infinity)
AUClast (Area Under the Concentration last)
AUEC of sCTX
Cl/F
Cmax
Emax of sCTX
Incidence of ADAs (Anti-Drug Antibodies)
Incidence of SAEs(Serious Adverse Events)
Incidence of TEAEs(Treatment Emergent Adverse Events)
Kel
Titer of ADAs
Tmax
Vd/F
t1/2

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.
1 of 2
Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injecti...
1 of 2

Active Control

Experimental Treatment

190 Total Participants · 2 Treatment Groups

Primary Treatment: Bmab 1000 · No Placebo Group · Phase 1

Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection.
Biological
Experimental Group · 1 Intervention: Bmab 1000 · Intervention Types: Biological
Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection.
Biological
ActiveComparator Group · 1 Intervention: Prolia® · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 to 36 week

Who is running the clinical trial?

Biocon Biologics UK LtdLead Sponsor
2 Previous Clinical Trials
864 Total Patients Enrolled
BiotrialIndustry Sponsor
6 Previous Clinical Trials
455 Total Patients Enrolled

Eligibility Criteria

Age 28 - 55 · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 60.0-95.0 kg, inclusive at screening.
You have no clinically relevant deviations according to the Investigator's judgment, or their designee's.
You have no signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator or their designee.

Who else is applying?

What state do they live in?
Massachusetts100.0%
How old are they?
65+100.0%
What site did they apply to?
Biotrial Inc100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%