Moderate to Severe Chronic Plaque PsoriasisPhase 1NCT06738277
This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).
A Phase 1 study testing Bmab 1200 (Biosimilar Ustekinumab) in people with Moderate to Severe Chronic Plaque Psoriasis, run by Biocon Biologics UK Ltd at 1 site in India.
Trial summary
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- Bmab 1200 (Biosimilar Ustekinumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteIndia
- Study dates
- 9 Jan 2025to 12 Jul 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a.Non-smokers, healthy, adult, human volunteers between 18 to 55 years of age (both inclusive).
- b.Having BMI between 18.5 to 28.0 m2 and having a body weight between 60 kg and 90 kg (both inclusive for both parameters).
- c.Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
- d.Able to understand and comply with the study procedures, in the opinion of the investigator.
- e.Able to give voluntary written informed consent for participation in the study.
- f.Subjects should not receive a BCG vaccine within 1 year before dosing and agree to not take it during the study and at least 1 year after dosing.
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- g.Subjects will agree not to receive live vaccination during the study. h.Subject will agree not to donate blood/ plasma/ platelets during the study and at least 3 months after the end of study.
- i.For male subjects i.Subjects agree to use effective contraception (e.g. Double barrier method) and refrain from donation of sperm from check-in until 90 days after the end of study.
- j.In case of female subjects: i.Surgically sterilized at least 6 months prior to study participation Or If subject is of child-bearing potential, is willing to use a suitable and effective double barrier contraceptive method or intrauterine device during the study and till 4 months after the end of study.
- Or Post-menopausal women. And ii.Serum pregnancy test must be negative. iii.Subjects will agree to refrain from donation of ova from check-in until 90 days after the end of study.
Who cannot join
- a. Known hypersensitivity or idiosyncratic reaction to ustekinumab or any excipients or any related drug or any substance (specifically any biologic product or the constituents of Bmab 1200).
- Known hypersensitivity to host cell [ murine myeloma cell or Chinese hamster ovary cells] derived proteins, latex), food, or other substance.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes.
- Use or intend to use any prescription medications/products or other acceptable concomitant Medications within 30 days prior to dosing or slow-release medications/products considered to still be active within 14 days prior to check-in.
- Use or intend to use any nonprescription medications/ products, including vitamins, minerals, and phytotherapeutic/ herbal/ plant-derived preparations within 7 days prior to check-in.
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- Use of any vaccine from 4 weeks prior to screening.
- The QTc interval more than 450 ms for male and more than 460 ms for female at the time of screening.
- Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.
- A recent history of harmful use of alcohol (less than 2 years), or consumption of alcohol or alcoholic products within 48 hours prior to receiving study drug.
- Smokers, or who have smoked within the last six months prior to the start of the study.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History or presence of seizure or psychiatric disorders.
- A history of difficulty with donating blood.
- Donation of blood (1 unit or 350 mL) or plasma/ platelets in the last 90 days prior to screening until 3 months after the end of study visit.
- Participation in a clinical study involving the administration of an investigational drug in the past 90 days or 5 half-lives (whichever is longer), prior to dosing.
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV antibody (I \&/or 2).
- Current history of active infections, including significant localized infections, cough or fever, or current /previous history of recurrent or chronic infections. (At screening and within 1 week prior to study drug administration).
- History of active tuberculosis (TB) or presence of active or latent TB. A positive result for IGRA (Interferon Gamma Release Assay) test at screening.
- Known history of previous exposure to ustekinumab or ustekinumab biosimilar, or any IL-12 or IL-23 monoclonal antibodies, approved or investigational.
- Consumption of grapefruit or grapefruit products within 72 hours prior to dosing.
- An unusual diet, for whatever reason (for example, fasting, high potassium or low sodium), for four weeks prior to receiving the study medicine. In any such case, subject selection will be at the discretion of the Principal Investigator.
- Ingestion of poppy seed-containing foods or beverages within 7 days prior to check-in.
- Receipt of blood products within 2 months prior to check-in. aa. Poor peripheral venous access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, 2-arm, Parallel Design Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, and Tolerability of Bmab 1200 -Autoinjector (Biosimilar Ustekinumab) After Single Subcutaneous Injection in Comparison With Bmab 1200 -Prefilled Syringe (Biosimilar Ustekinumab)
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS).
Read the detailed description
Bmab 1200 is being developed as a proposed biosimilar product to the reference product Stelara® in accordance with EU and US biosimilar guidelines. The currently available Bmab 1200 formulation is administered via SC injection using PFS (similar to the reference product Stelara®). The main purpose of this study is to establish the PK equivalence of Bmab 1200 -AI following a single SC injection ( 45 mg) in comparison with Bmab 1200 -PFS. AI and PFS are self-injectable devices that can deliver drugs through the SC route. This study will also assess the safety and tolerability of Bmab 1200 AI in comparison with Bmab 1200 PFS. This will enable the licensure of AI to improve patient compliance through controlled and standardized administration of Bmab 1200
- Being tested
- Bmab 1200 (Biosimilar Ustekinumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmab 1200 (Biosimilar Ustekinumab)Drug
Dosage Form: injection, Strength(s): 45 mg/ 0.5 mL Route of Administration: Subcutaneous Frequency and Dose: 45 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| Bmab 1200 AI (Biosimilar Ustekinumab) | Experimental | Not described Receives: Drug: Bmab 1200 (Biosimilar Ustekinumab) |
| Bmab 1200 PFS (Biosimilar Ustekinumab) | Active comparator | Not described Receives: Drug: Bmab 1200 (Biosimilar Ustekinumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration (Cmax) of drug Bmab 1200
Measured: Week 16
AUCo-∞
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: Week 16
Secondary outcomes (7)
AUCo-t
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification
Measured: Week 16
Tmax
Time to maximum observed concentration
Measured: Week 16
AUC_%Extrap_obs
% of the AUC that has been derived after extrapolation
Measured: Week 16
ƛz
Elimination rate constant
Measured: Week 16
Vd
Volume of distribution
Measured: Week 16
Cl
drug clearance
Measured: Week 16
t1/2
Apparent terminal elimination half-life
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start9 Jan 2025
- Primary completion12 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Plaque PsoriasisStudies 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
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738277
- Sponsor's protocol ID
- BIO-USTEKI-104
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, 2-arm, Parallel Design Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, and Tolerability of Bmab 1200 -Autoinjector (Biosimilar Ustekinumab) After Single Subcutaneous Injection in Comparison With Bmab 1200 -Prefilled Syringe (Biosimilar Ustekinumab)
- ClinicalTrials.gov ID
- NCT06738277
- Acronym / sponsor ID
- BIO-USTEKI-104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Biocon Biologics UK LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 17 Dec 2024 (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 is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab 1200 -prefilled syringe (PFS).
Detailed description
Bmab 1200 is being developed as a proposed biosimilar product to the reference product Stelara® in accordance with EU and US biosimilar guidelines. The currently available Bmab 1200 formulation is administered via SC injection using PFS (similar to the reference product Stelara®). The main purpose of this study is to establish the PK equivalence of Bmab 1200 -AI following a single SC injection ( 45 mg) in comparison with Bmab 1200 -PFS. AI and PFS are self-injectable devices that can deliver drugs through the SC route. This study will also assess the safety and tolerability of Bmab 1200 AI in comparison with Bmab 1200 PFS. This will enable the licensure of AI to improve patient compliance through controlled and standardized administration of Bmab 1200
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bmab 1200 AI (Biosimilar Ustekinumab) | Experimental | Drug: Bmab 1200 (Biosimilar Ustekinumab) |
| Bmab 1200 PFS (Biosimilar Ustekinumab) | Active comparator | Drug: Bmab 1200 (Biosimilar Ustekinumab) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- a.Non-smokers, healthy, adult, human volunteers between 18 to 55 years of age (both inclusive).
- b.Having BMI between 18.5 to 28.0 m2 and having a body weight between 60 kg and 90 kg (both inclusive for both parameters).
- c.Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
- d.Able to understand and comply with the study procedures, in the opinion of the investigator.
- e.Able to give voluntary written informed consent for participation in the study.
Key exclusion criteria (26 listed)
- a. Known hypersensitivity or idiosyncratic reaction to ustekinumab or any excipients or any related drug or any substance (specifically any biologic product or the constituents of Bmab 1200).
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 1200 (Biosimilar Ustekinumab)Dosage Form: injection, Strength(s): 45 mg/ 0.5 mL Route of Administration: Subcutaneous Frequency and Dose: 45 mg, single dose | Drug | Bmab 1200 AI (Biosimilar Ustekinumab), Bmab 1200 PFS (Biosimilar Ustekinumab) |
Primary outcome
Cmax
Time frame: Week 16
Maximum observed concentration (Cmax) of drug Bmab 1200
AUCo-∞
Time frame: Week 16
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)
7 secondary outcomes
AUCo-t
Time frame: Week 16
Tmax
Time frame: Week 16
AUC_%Extrap_obs
Time frame: Week 16
ƛz
Time frame: Week 16
Vd
Time frame: Week 16
Cl
Time frame: Week 16
t1/2
Time frame: Week 16
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 19 Aug 2025.
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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 1200 (Biosimilar Ustekinumab) in people with Moderate to Severe Chronic Plaque Psoriasis, run by Biocon Biologics UK Ltd at 1 site in India.
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 10 inclusion and 26 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 19 Aug 2025. 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 India. 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?
Cmax (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.