PsoriasisPhase 1NCT04371185
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects
A Phase 1 study testing BAT2206, Stelara(US-licensed) and Stelara(EU-licensed) in people with Psoriasis, run by Bio-Thera Solutions at 1 site in China.
Trial summary
It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- BAT2206, Stelara(US-licensed) and Stelara(EU-licensed)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2020to 19 Apr 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese male healthy subjects aged from 18 to 55 years (including the boundary value)；
- BMI between 18-28kg/m2 (including boundary value) and body weight between 55-85kg;
- Normal physical examination results or abnormal with no clinical significance according to the doctor's judgment;
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study, and voluntarily adopts effective contraceptive measures;
- Sign the informed consent before joining the study, and fully understand the content, process and possible risks;
- Willing and able to comply with the visits and treatments of the trial protocol.
Who cannot join
- Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases with clinical significance within one year prior to screening;
- ECG is abnormal and has clinical significance (judged by the investigator);
- With active infection within two months before screening, including acute and chronic infection and local infection;
- Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive;
- Having taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days before screening (or within 5 half-lives of the above drugs, whichever is longer);
- Having participated in drug clinical trials within 3 months before the study administration, or planning to participate in other drug clinical trials during the study period;
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- Acute disease occurred or with concomitant medication from the screening to use of the study drug; major injury or surgery or fracture occurred within 4 weeks before enrollment, or surgery was planned during the study;
- Having used ustekinumab, anti-tumor necrosis factor (TNF) or interleukin (IL) targeting agents, or having used any biological products or monoclonal antibodies within 3 months before screening;
- Any immunoglobulin biologicals were used one year prior to screening;
- Having received within 12 weeks prior to initiating treatment or planning to receive live virus or live vaccines during the study;
- Suspected or confirmed as allergic constitution (allergic to variety of drugs or food), or allergic to ustekinumab, or severe allergic or allergic reaction to monoclonal antibody;
- Blood donation or massive blood loss (> 450 ml) within 3 months before using the study drug, or planning to donate blood during the study, or having received blood transfusion within 8 weeks before screening;
- Employees or relatives of all investigators, clinical centers, clinical research organizations or sponsors cannot be included in the group;
- Subjects considered unsuitable by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects
It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).
Read the detailed description
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the similarity of the pharmacokinetics of the three study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
- Conditions
- Psoriasis
- Being tested
- BAT2206, Stelara(US-licensed), Stelara(EU-licensed)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT2206Drug
45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
Stelara(US-licensed)Drug
Also called Ustekinumab
45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
Stelara(EU-licensed)Drug
Also called Ustekinumab
45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| BAT2206 injection | Experimental | 45mg; subcutaneous injection Receives: Drug: BAT2206 |
| Stelara(US-licensed) | Active comparator | 45mg; subcutaneous injection Receives: Drug: Stelara(US-licensed) |
| Stelara(EU-licensed) | Active comparator | 45mg; subcutaneous injection Receives: Drug: Stelara(EU-licensed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint: Peak plasma concentration (Cmax)
Measured: 0-4months
Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf)
Measured: 0-4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start8 Aug 2020
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Principal investigator, the First Hospital of Jinlin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371185
- Sponsor's protocol ID
- BAT-2206-001-CR
- Status last verified
- Sep 2021
- First submitted
- 23 Mar 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only one site study
Publications
Wu M, Li X, Yang D, Wang M, Zhang H, Li C, Mai J, Yang L, Qi Y, Yu JC, Yang X, Wang Z, Gu C, Ding Y. Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. BioDrugs. 2023 Jan;37(1):89-98. doi: 10.1007/s40259-022-00563-5. Epub 2022 Nov 22.
PubMed 36417156
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT04371185
- Acronym / sponsor ID
- BAT-2206-001-CR
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 1 May 2020 (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.
It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).
Detailed description
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the similarity of the pharmacokinetics of the three study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAT2206 injection | Experimental | Drug: BAT220645mg; subcutaneous injection |
| Stelara(US-licensed) | Active comparator | Drug: Stelara(US-licensed)45mg; subcutaneous injection |
| Stelara(EU-licensed) | Active comparator | Drug: Stelara(EU-licensed)45mg; subcutaneous injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese male healthy subjects aged from 18 to 55 years (including the boundary value)；
- BMI between 18-28kg/m2 (including boundary value) and body weight between 55-85kg;
- Normal physical examination results or abnormal with no clinical significance according to the doctor's judgment;
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study, and voluntarily adopts effective contraceptive measures;
- Sign the informed consent before joining the study, and fully understand the content, process and possible risks;
Key exclusion criteria (14 listed)
- Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases with clinical significance within one year prior to screening;
- ECG is abnormal and has clinical significance (judged by the investigator);
- With active infection within two months before screening, including acute and chronic infection and local infection;
- Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive;
- Having taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days before screening (or within 5 half-lives of the above drugs, whichever is longer);
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 |
|---|---|---|
| BAT220645mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection | Drug | BAT2206 injection |
| Stelara(US-licensed)Also: Ustekinumab45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection | Drug | Stelara(US-licensed) |
| Stelara(EU-licensed)Also: Ustekinumab45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection | Drug | Stelara(EU-licensed) |
Primary outcome
Pharmacokinetics Endpoint: Peak plasma concentration (Cmax)
Time frame: 0-4months
Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf)
Time frame: 0-4months
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 13 Sep 2021.
- Derived from this study: PubMed 36417156Wu M, Li X, Yang D, Wang M, Zhang H, Li C, Mai J, Yang L, Qi Y, Yu JC, Yang X, Wang Z, Gu C, Ding Y. Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. BioDrugs. 2023 Jan;37(1):89-98. doi: 10.1007/s40259-022-00563-5. Epub 2022 Nov 22.
- Individual participant dataSharing planned: No. Only one site study
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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.
Yanhua Ding principal investigator
the First Hospital of Jinlin University
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 BAT2206, Stelara(US-licensed) and Stelara(EU-licensed) in people with Psoriasis, run by Bio-Thera Solutions at 1 site in China.
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 14 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 13 Sep 2021. 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 China. 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?
Pharmacokinetics Endpoint: Peak plasma concentration (Cmax) (time frame: 0-4months). 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?
On the ClinicalTrials.gov record for NCT04371185, 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 13 Sep 2021.