Severe AsthmaPhase 1NCT05576454
Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects
A Phase 1 study testing Mepolizumab Injection (BAT2606 Injection), Mepolizumab Injection (EU-licensed Nucala) and Mepolizumab Injection (US-licensed Nucala) in people with Severe Asthma, run by Bio-Thera Solutions at 1 site in China.
Trial summary
To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China 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
- Severe Asthma
- What is being tested?
- Mepolizumab Injection (BAT2606 Injection), Mepolizumab Injection (EU-licensed Nucala) and Mepolizumab Injection (US-licensed Nucala)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 19 Jun 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Subjects have signed the informed consent before the trial, and fully understood the content, process and relevant risks of the trial.
- 2. Subjects who are able to complete the study in accordance with the requirements of the protocol.
- 3. Visiting subjects (including partners) who are willing to comply with the study provisions agree to have no pregnancy plans and no donor sperm plans throughout the trial and for 6 months after dosing, and to voluntarily use effective contraception, as described in Appendix 4.
- 4. Subjects with BMI between 18 and 28 kg/m2 (both inclusive) and body weight between 55 and 85 kg (both inclusive).
- 5. Healthy Chinese male subjects between the ages of 18 and 55 years (both inclusive).
- 6. Subjects with normal or abnormal physical examinations without clinical significance.
Who cannot join
- 1. Subjects who have clinically significant abnormalities in clinical laboratory tests.
- 2. Subjects with clinical significance of abnormal ECG, chest x-ray.
- 3. Subjects with history of hypertension.
- 4. Subject who are or had been suffering from malignant neoplasm; subject who are or had been suffering from inflammatory bowel disease.
- 5. Subjects who have an active infection within 2 months prior to screening, including acute and chronic infections as well as localized infections.
- 6. Subjects who have active tuberculosis.
Show all 21Show fewer
- 7. Subjects who have been exposed to TB within 3 months prior to screening.
- 8. Subjects whose T-cell test for tuberculosis infection (T-SPOT.TB) results are positive.
- 9. Subjects who are positive for HBsAg on the hepatitis B half test.
- 10. Subjects who have had a major injury or undergone previous surgical procedures or fracture within 4 weeks prior to enrollment.
- 11. Subjects who have taken any prescription medication within 28 days prior to screening.
- 12. Subjects who participate in another drug clinical trial within 3 months prior to enrollment.
- 13. Subjects who suffered an acute illness from the screening period until study drug administration.
- 14. Subjects who have received Mepolizumab (or its biosimilar) within 6 months (or within 5 half-lives of the drug, whichever is longer) prior to screening.
- 15. Subjects who have received live vaccination during the study period within 12 weeks prior to study dosing.
- 16. Subjects who are suspected or confirmed to be allergic (allergic to multiple medications or foods).
- 17. Subjects who smoked more than 5 cigarettes per day in the 3 months prior to screening.
- 18. Subjects who have taken any alcohol-containing product within 24h prior to study dosing.
- 19. Subjects who have donated blood or lost a significant amount of blood (> 450 mL) within 3 months prior to study drug administration.
- 20. Subjects with a positive urine drug screening.
- 21. Subject who is deemed unsuitable for enrollment by the investigator.
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 on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection (EU-licensed Nucala® and US-licensed Nucala®) in Healthy Chinese Male Subjects
To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.
Read the detailed description
This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.
- Conditions
- Severe Asthma
- Being tested
- Mepolizumab Injection (BAT2606 Injection), Mepolizumab Injection (EU-licensed Nucala), Mepolizumab Injection (US-licensed Nucala)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab Injection (BAT2606 Injection)Drug
Also called BAT2606 Injection
In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.
Mepolizumab Injection (EU-licensed Nucala)Drug
Also called EU-licensed Nucala
In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).
Mepolizumab Injection (US-licensed Nucala)Drug
Also called US-licensed Nucala
In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).
| Study group | Role | What they receive |
|---|---|---|
| BAT2606 Injection | Experimental | PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. Receives: Drug: Mepolizumab Injection (BAT2606 Injection) |
| Mepolizumab Injection (EU-licensed Nucala®) | Active comparator | PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. Receives: Drug: Mepolizumab Injection (EU-licensed Nucala) |
| Mepolizumab Injection (US-licensed Nucala®) | Active comparator | PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. Receives: Drug: Mepolizumab Injection (US-licensed Nucala) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum blood concentration
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
AUC0-∞
Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Secondary outcomes (8)
AUC0-t
Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Tmax
Observed time to peak concentration
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
t1/2
Elimination half-life t1/2 = 0.693/λz
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
CL/F
Total clearance rate, CL/F=Dose/AUC0-∞
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Vd
Apparent volume of distribution, Vd =Dose/(AUC0-∞ × λz)
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
λz
Terminal elimination rate constant. The negative of the slope value obtained by taking the logarithm of the drug concentration and performing a linear regression against time is the terminal elimination rate constant
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Adverse events
AE and SAE
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Immunogenicity
Anti-drug antibody (ADA) positivity, ADA titer and neutralizing antibody (NAb) positivity for ADA.
Measured: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start20 Sep 2022
- Primary completion26 May 2023
- Study completion19 Jun 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 Severe AsthmaStudies 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
- Model description
- It's a randomized, double-blinded, single-dose, 3-arm parallel comparative study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576454
- Sponsor's protocol ID
- BAT-2606-001-CR
- Status last verified
- Feb 2023
- First submitted
- 8 Oct 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li C, Sun J, Xu J, Wu M, Li X, Liu Z, Dong Q, Sun Y, Ding Y. Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial. Front Pharmacol. 2025 Jul 25;16:1580883. doi: 10.3389/fphar.2025.1580883. eCollection 2025.
PubMed 40786037
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. 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 on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection (EU-licensed Nucala® and US-licensed Nucala®) in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05576454
- Acronym / sponsor ID
- BAT-2606-001-CR
- Conditions
- Severe Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 12 Oct 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.
To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.
Detailed description
This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- It's a randomized, double-blinded, single-dose, 3-arm parallel comparative study.
| Arm | Type | Receives |
|---|---|---|
| BAT2606 Injection | Experimental | Drug: Mepolizumab Injection (BAT2606 Injection)PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. |
| Mepolizumab Injection (EU-licensed Nucala®) | Active comparator | Drug: Mepolizumab Injection (EU-licensed Nucala)PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. |
| Mepolizumab Injection (US-licensed Nucala®) | Active comparator | Drug: Mepolizumab Injection (US-licensed Nucala)PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Subjects have signed the informed consent before the trial, and fully understood the content, process and relevant risks of the trial.
- 2. Subjects who are able to complete the study in accordance with the requirements of the protocol.
- 3. Visiting subjects (including partners) who are willing to comply with the study provisions agree to have no pregnancy plans and no donor sperm plans throughout the trial and for 6 months after dosing, and to voluntarily use effective contraception, as described in Appendix 4.
- 4. Subjects with BMI between 18 and 28 kg/m2 (both inclusive) and body weight between 55 and 85 kg (both inclusive).
- 5. Healthy Chinese male subjects between the ages of 18 and 55 years (both inclusive).
Key exclusion criteria (21 listed)
- 1. Subjects who have clinically significant abnormalities in clinical laboratory tests.
- 2. Subjects with clinical significance of abnormal ECG, chest x-ray.
- 3. Subjects with history of hypertension.
- 4. Subject who are or had been suffering from malignant neoplasm; subject who are or had been suffering from inflammatory bowel disease.
- 5. Subjects who have an active infection within 2 months prior to screening, including acute and chronic infections as well as localized infections.
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 |
|---|---|---|
| Mepolizumab Injection (BAT2606 Injection)Also: BAT2606 InjectionIn this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection. | Drug | BAT2606 Injection |
| Mepolizumab Injection (EU-licensed Nucala)Also: EU-licensed NucalaIn this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®). | Drug | Mepolizumab Injection (EU-licensed Nucala®) |
| Mepolizumab Injection (US-licensed Nucala)Also: US-licensed NucalaIn this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®). | Drug | Mepolizumab Injection (US-licensed Nucala®) |
Primary outcome
Cmax
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Maximum blood concentration
AUC0-∞
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz
8 secondary outcomes
AUC0-t
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Tmax
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
t1/2
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
CL/F
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Vd
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
λz
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Adverse events
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
Immunogenicity
Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113
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 28 Aug 2023.
- Derived from this study: PubMed 40786037Li C, Sun J, Xu J, Wu M, Li X, Liu Z, Dong Q, Sun Y, Ding Y. Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial. Front Pharmacol. 2025 Jul 25;16:1580883. doi: 10.3389/fphar.2025.1580883. eCollection 2025.
- Individual participant dataSharing planned: No
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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, PhD 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 Mepolizumab Injection (BAT2606 Injection), Mepolizumab Injection (EU-licensed Nucala) and Mepolizumab Injection (US-licensed Nucala) in people with Severe Asthma, 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 21 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 28 Aug 2023. 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?
Cmax (time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113). 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 NCT05576454, 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 28 Aug 2023.