Healthy VolunteersPhase 1DENARIUSNCT05323708
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
A Phase 1 study testing Bmab 1000 and Prolia® in people with Healthy Volunteers, run by Biocon Biologics UK Ltd at 1 site in United States.
Trial summary
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 28 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bmab 1000 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 6 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Investigator or their designee.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Two-arm, Single-dose, Parallel-Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- Bmab 1000, Prolia®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmab 1000Biological
60mg/ml Prefilled syringe single dose
Prolia®Biological
60mg/ml Prefilled syringe single dose
| Study group | Role | What they receive |
|---|---|---|
| Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection. | Experimental | Not described Receives: Biological: Bmab 1000 |
| Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection. | Active comparator | Not described Receives: Biological: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf (Area Under the Concentration infinity)
Area under the concentration-time curve from time zero to infinity
Measured: 0 to 36 week
AUClast (Area Under the Concentration last)
Area under the concentration-time curve from time zero to last quantifiable concentration
Measured: 0 to 36 week
Cmax
Maximum serum concentration
Measured: 0 to 36 week
Secondary outcomes (11)
Tmax
Time to reach Cmax
Measured: 0 to 36 week
t1/2
Terminal half-life
Measured: 0 to 36 week
Kel
Terminal elimination rate constant (kel)
Measured: 0 to 36 week
Vd/F
Apparent volume of distribution
Measured: 0 to 36 week
Cl/F
Apparent clearance
Measured: 0 to 36 week
AUEC of sCTX
Area under the effect curve (AUEC) of serum concentration of C-terminal telopeptide of Type 1 collagen (sCTX)
Measured: 0 to 36 week
Emax of sCTX
Maximal inhibitory effect (Emax) of sCTX
Measured: 0 to 36 week
Incidence of TEAEs(Treatment Emergent Adverse Events)
Experience at least 1 TEAE
Measured: 0 to 36 week
Incidence of SAEs(Serious Adverse Events)
Experience at least 1 SAE
Measured: 0 to 36 week
Incidence of ADAs (Anti-Drug Antibodies)
Incidence of ADAs to denosumab
Measured: 0 to 36 week
Titer of ADAs
Titer of ADAs to denosumab
Measured: 0 to 36 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start9 Mar 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323708
- Sponsor's protocol ID
- B1000-NHV-01-G-01
- Acronym
- DENARIUS
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krishnan A, Bp S, Mehta G, Ramaswamy S, Chakraborty S, Mandal S. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. Bioanalysis. 2026 Aug 26:1-14. doi: 10.1080/17576180.2026.2715917. Online ahead of print.
PubMed 42643157
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Two-arm, Single-dose, Parallel-Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05323708
- Acronym / sponsor ID
- DENARIUS / B1000-NHV-01-G-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Biocon Biologics UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- Biotrial
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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® |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bmab 100060mg/ml Prefilled syringe single dose | Biological | Bmab 1000, A single 60 mg dose of Bmab 1000 administered by subcutaneous injection. |
| Prolia®60mg/ml Prefilled syringe single dose | Biological | Prolia®, A single 60 mg dose of Prolia® administered by subcutaneous injection. |
Primary outcome
AUCinf (Area Under the Concentration infinity)
Time frame: 0 to 36 week
Area under the concentration-time curve from time zero to infinity
AUClast (Area Under the Concentration last)
Time frame: 0 to 36 week
Area under the concentration-time curve from time zero to last quantifiable concentration
Cmax
Time frame: 0 to 36 week
Maximum serum concentration
11 secondary outcomes
Tmax
Time frame: 0 to 36 week
t1/2
Time frame: 0 to 36 week
Kel
Time frame: 0 to 36 week
Vd/F
Time frame: 0 to 36 week
Cl/F
Time frame: 0 to 36 week
AUEC of sCTX
Time frame: 0 to 36 week
Emax of sCTX
Time frame: 0 to 36 week
Incidence of TEAEs(Treatment Emergent Adverse Events)
Time frame: 0 to 36 week
Incidence of SAEs(Serious Adverse Events)
Time frame: 0 to 36 week
Incidence of ADAs (Anti-Drug Antibodies)
Time frame: 0 to 36 week
Titer of ADAs
Time frame: 0 to 36 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 42643157Krishnan A, Bp S, Mehta G, Ramaswamy S, Chakraborty S, Mandal S. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. Bioanalysis. 2026 Aug 26:1-14. doi: 10.1080/17576180.2026.2715917. Online ahead of print.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bmab 1000 and Prolia® in people with Healthy Volunteers, run by Biocon Biologics UK Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCinf (Area Under the Concentration infinity) (time frame: 0 to 36 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.