Healthy MenPhase 1NCT05968508
A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects
A Phase 1 study testing BAT1806 prefilled subcutaneous injection/RoActemra® (from EU) in people with Healthy Men, run by Bio-Thera Solutions at 1 site in China.
Trial summary
This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy 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
- Healthy Men
- What is being tested?
- BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2023to 8 Oct 2024
- 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
- Subjects can be enrolled only when they meet all the following inclusion criteria:
- Signed the informed consent form prior to the study, sufficient understanding of the content, procedure and possible adverse reactions of the study;
- Willing and able to comply with the visit and treatment specified in the 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 the detailed contraceptive measures;
- Healthy male subjects aged 18～55 years (inclusive);
- BMI ranging from 18.0～28.0 kg/m2 (inclusive), and weight ranging from 55.0～85.0 kg (inclusive);
- Normal or abnormal physical examination that is judged as clinically insignificant;
Who cannot join
- Subjects can not be enrolled in this study if any of the following criteria is met:
- Smoking >5 cigarettes per day within three months prior to the study;
- Any serious allergic reaction to food or drug at present or in the past, or allergy to Tocilizumab, or serious allergy or allergic reaction to human, humanized or murine monoclonal antibody;
- History of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL liquor, or 125 mL wine);
- Blood donation or massive blood loss (>450 mL) within three months prior to screening, or plan for blood donation or surgery during the study;
- Intake of any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days prior to screening;
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- Great change in dietary or exercise habit within 2 weeks prior to screening or from screening to administration;
- Having any disease that may increase hemorrhagic risk, such as haemorrhoids with hemorrhagic symptoms, acute gastritis or gastric and duodenal ulcer;
- Clinically significant abnormality in echocardiography;
- Clinically significant abnormality in clinical laboratory examination, or other clinical findings showing the following disorders of clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and cardiovascular diseases);
- Clinically significant (judged by investigators) abnormality in ECG, or QTcF > 450ms (allowed to be repeated for once, the subject needs to be excluded if the two measurements of QTcF are > 450ms);
- Acute disease or concomitant medication from screening to prior to administration of study drug;
- Positive urine drug screen, or history of drug abuse or use of narcotics in the past 5 years;
- Positive HBsAg in five hepatitis B markers at screening; or positive anti-HBc and negative anti-HBs; or positive hepatitis C antibody; or positive HIV antibody; or positive Treponema pallidum antibody;
- Intake of any alcohol-containing product within 48 hours prior to dosing of study drug, or failure to limit alcohol consumption as required during the study;
- Currently or previously having malignant tumor;
- History of hypertension, or systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥90 mmHg at screening/baseline (allowed to be repeated for once, the subject needs to be excluded if the two measurements of systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥90 mmHg);
- Patients with hepatic disorder who are judged by investigators as inappropriate for enrollment;
- Presence of active infection, including acute and chronic infection as well as local infection;
- Chest X-ray showing active pulmonary tuberculosis; or previous history of tuberculosis or latent tuberculosis infection, or clinical manifestations suspected as tuberculosis (including but not limited to pulmonary tuberculosis); Positive for T-SPOT®.TB interferon-γ-release assays, or contact with patients with tuberculosis within three months or/and symptoms or/and signs suspected as tuberculosis;
- Had received or plan to receive live virus vaccine or immunosuppressant within 12 weeks prior to administration of study drug;
- Having participated in drug clinical trial within three months prior to the first dose of study drug, or plan to participate in other drug clinical trial during the study;
- Those who are considered by investigators as inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.
Read the detailed description
A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.
A 14-day screening period is set in this study. Subjects will be admitted one day prior to administration (Day -1) and can be discharged only upon completion of relevant observations and evaluations after administration on Day 5. After discharge, subjects need to return to the hospital for 10 follow-ups as required in the study.
- Conditions
- Healthy Men
- Being tested
- BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)Drug
A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| BAT1806 prefilled subcutaneous injection | Experimental | Not described Receives: Drug: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU) |
| RoActemra® (from EU) | Active comparator | Not described Receives: Drug: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Measured: from Day0 to Day57
AUC0-t
Measured: from Day0 to Day57
Cmax
Measured: from Day0 to Day57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start29 Aug 2023
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
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 MenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, Ph.D, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968508
- Sponsor's protocol ID
- BAT-1806-003-CR
- Status last verified
- May 2025
- First submitted
- 20 Jul 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang Q, Jiang Y, Liu Z, Wu J, Dong Q, Liu Y, Qin H, Zhang Q, Zhang Q, Hu W. A randomized, double-blind, single-dose, parallel two-group study comparing the pharmacokinetics, safety, and immunogenicity of BAT1806 SC with tocilizumab in healthy Chinese male subjects. Expert Opin Biol Ther. 2025 Oct;25(10):1101-1111. doi: 10.1080/14712598.2025.2574006. Epub 2025 Oct 14.
PubMed 41069221
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05968508
- Acronym / sponsor ID
- BAT-1806-003-CR
- Conditions
- Healthy Men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 1 Aug 2023 (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 a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.
Detailed description
A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.
A 14-day screening period is set in this study. Subjects will be admitted one day prior to administration (Day -1) and can be discharged only upon completion of relevant observations and evaluations after administration on Day 5. After discharge, subjects need to return to the hospital for 10 follow-ups as required in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAT1806 prefilled subcutaneous injection | Experimental | Drug: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU) |
| RoActemra® (from EU) | Active comparator | Drug: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects can be enrolled only when they meet all the following inclusion criteria:
Key exclusion criteria (23 listed)
- Subjects can not be enrolled in this study if any of the following criteria is met:
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 prefilled subcutaneous injection/RoActemra® (from EU)A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously. | Drug | BAT1806 prefilled subcutaneous injection, RoActemra® (from EU) |
Primary outcome
AUC0-inf
Time frame: from Day0 to Day57
AUC0-t
Time frame: from Day0 to Day57
Cmax
Time frame: from Day0 to Day57
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 29 May 2025.
- Derived from this study: PubMed 41069221Yang Q, Jiang Y, Liu Z, Wu J, Dong Q, Liu Y, Qin H, Zhang Q, Zhang Q, Hu W. A randomized, double-blind, single-dose, parallel two-group study comparing the pharmacokinetics, safety, and immunogenicity of BAT1806 SC with tocilizumab in healthy Chinese male subjects. Expert Opin Biol Ther. 2025 Oct;25(10):1101-1111. doi: 10.1080/14712598.2025.2574006. Epub 2025 Oct 14.
Related trials for Healthy Men
Active, not recruiting
Project 1: Diet and Exercise Modulate the Sperm Epigenome in Men
Healthy Lifestyle, Obese
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.
Wei Hu, Ph.D principal investigator
The Second Hospital of Anhui Medical 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 prefilled subcutaneous injection/RoActemra® (from EU) in people with Healthy Men, 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 7 inclusion and 23 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 29 May 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 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?
AUC0-inf (time frame: from Day0 to Day57). 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 NCT05968508, 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 29 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.