Rheumatoid ArthritisPhase 1NCT03606876
Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects
A Phase 1 study testing BAT1806 injection in people with Rheumatoid Arthritis, 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 BAT1806 Injection vs Actemra® (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
- Rheumatoid Arthritis
- What is being tested?
- BAT1806 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2018to 17 Jul 2019
- 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
- Signed the Inform Consent Form and fully understood the trial conduction, procedure and potential adverse reactions before entering the trial;
- Willing and able to follow the visits, treatments specified in this study;
- Subjects (including their partners) who are willing to refrain from pregnancy, sperm donation and take effective contraceptive method in the future 6 months (i.e. 6 months after study medication), see Appendix 4 for specific contraceptive methods;
- Healthy male subjects at age of 18-55 years (inclusive for both);
- BMI between 18-28 kg/m2 (inclusive for both) and body weight between 55-85 kg (inclusive for both);
- Normal physical examinations results or abnormality without clinical significance.
Who cannot join
- Daily smoking amount of >5 cigarettes within 3 months prior to the trial;
- Any current or history of severe allergic reaction to foods or drugs and History of allergy to tocilizumab or severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
- Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or 25 mL spirit, or 125 mL wine);
- Having donated blood or loss of massive blood (> 450 mL) within 3 months prior to screening, or planning to donate blood or to receive surgery during the study;
- Prior use of prescription medication, over-the-counter drugs, any vitamin products or herbs within 28 days before screening;
- Having significant changes in diet and exercise habits within 2 weeks before screening or from screening to dose;
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- Having any diseases that increase the risk of bleeding, such as hemorrhoids with bleeding symptoms, acute gastritis or gastric and duodenal ulcers;
- Color Doppler echocardiography abnormalities with clinical significance;
- Having clinically significant laboratory abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
- Ineligible subjects based on investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® 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 BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and 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
- Rheumatoid Arthritis
- Being tested
- BAT1806 injection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT1806 injectionDrug
Also called Actemra(EU-licensed), Actemra(US-licensed)
Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
| Study group | Role | What they receive |
|---|---|---|
| BAT1806 injection | Experimental | BAT1806 injection: 4 mg/kg, intravenous infusion over 60 min Receives: Drug: BAT1806 injection |
| Actemra(EU-licensed) | Active comparator | Actemra(EU-licensed): 4 mg/kg, intravenous infusion over 60 min Receives: Drug: BAT1806 injection |
| Actemra(US-licensed) | Active comparator | Actemra(US-licensed): 4 mg/kg, intravenous infusion over 60 min Receives: Drug: BAT1806 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint
AUC0-inf
Measured: 0-2months
Secondary outcomes (2)
Pharmacokinetics Endpoint
AUC0-t
Measured: 0-2months
Pharmacokinetics Endpoint
Cmax
Measured: 0-2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start13 Jun 2018
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- 138 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 Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606876
- Sponsor's protocol ID
- BAT-1806-001-CR
- Status last verified
- Nov 2021
- First submitted
- 12 Jul 2018
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only one site study
Publications
Ebbers HC, Taylor PC, Leng X, Wei W, Kinsella NM, Zhou Y, Yang X, Chamberlain P. A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. Rheumatol Ther. 2025 Jun;12(3):529-546. doi: 10.1007/s40744-025-00760-y. Epub 2025 Apr 8.
PubMed 40198544Zhang H, Wang H, Wei H, Chen H, Liu J, Li C, Zhu X, Li X, Yu J, Zhou Y, Yang X, Wang Z, Wu M, Ding Y. A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men. Front Pharmacol. 2021 Jan 25;11:609522. doi: 10.3389/fphar.2020.609522. eCollection 2020.
PubMed 33569002
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT03606876
- Acronym / sponsor ID
- BAT-1806-001-CR
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 31 Jul 2018 (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 BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and 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 |
|---|---|---|
| BAT1806 injection | Experimental | Drug: BAT1806 injectionBAT1806 injection: 4 mg/kg, intravenous infusion over 60 min |
| Actemra(EU-licensed) | Active comparator | Drug: BAT1806 injectionActemra(EU-licensed): 4 mg/kg, intravenous infusion over 60 min |
| Actemra(US-licensed) | Active comparator | Drug: BAT1806 injectionActemra(US-licensed): 4 mg/kg, intravenous infusion over 60 min |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed the Inform Consent Form and fully understood the trial conduction, procedure and potential adverse reactions before entering the trial;
- Willing and able to follow the visits, treatments specified in this study;
- Subjects (including their partners) who are willing to refrain from pregnancy, sperm donation and take effective contraceptive method in the future 6 months (i.e. 6 months after study medication), see Appendix 4 for specific contraceptive methods;
- Healthy male subjects at age of 18-55 years (inclusive for both);
- BMI between 18-28 kg/m2 (inclusive for both) and body weight between 55-85 kg (inclusive for both);
Key exclusion criteria (10 listed)
- Daily smoking amount of >5 cigarettes within 3 months prior to the trial;
- Any current or history of severe allergic reaction to foods or drugs and History of allergy to tocilizumab or severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
- Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or 25 mL spirit, or 125 mL wine);
- Having donated blood or loss of massive blood (> 450 mL) within 3 months prior to screening, or planning to donate blood or to receive surgery during the study;
- Prior use of prescription medication, over-the-counter drugs, any vitamin products or herbs within 28 days before screening;
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 |
|---|---|---|
| BAT1806 injectionAlso: Actemra(EU-licensed), Actemra(US-licensed)Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed). | Drug | Actemra(EU-licensed), Actemra(US-licensed), BAT1806 injection |
Primary outcome
Pharmacokinetics Endpoint
Time frame: 0-2months
AUC0-inf
2 secondary outcomes
Pharmacokinetics Endpoint
Time frame: 0-2months
Pharmacokinetics Endpoint
Time frame: 0-2months
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 18 Nov 2021.
- Derived from this study: PubMed 40198544Ebbers HC, Taylor PC, Leng X, Wei W, Kinsella NM, Zhou Y, Yang X, Chamberlain P. A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. Rheumatol Ther. 2025 Jun;12(3):529-546. doi: 10.1007/s40744-025-00760-y. Epub 2025 Apr 8.
- Derived from this study: PubMed 33569002Zhang H, Wang H, Wei H, Chen H, Liu J, Li C, Zhu X, Li X, Yu J, Zhou Y, Yang X, Wang Z, Wu M, Ding Y. A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men. Front Pharmacol. 2021 Jan 25;11:609522. doi: 10.3389/fphar.2020.609522. eCollection 2020.
- 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 Jilin 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 BAT1806 injection in people with Rheumatoid Arthritis, 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 10 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 18 Nov 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 (time frame: 0-2months). 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 NCT03606876, which also lists 2 linked publications.
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 18 Nov 2021.