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CompletedNCT05576454Updated Aug 28, 2023

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

A Phase 1 interventional study of Mepolizumab Injection (BAT2606 Injection) and Mepolizumab Injection (EU-licensed Nucala) in Severe Asthma, sponsored by Bio-Thera Solutions. Completed at 1 site in China. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by Bio-Thera Solutions · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
207
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Severe Asthma

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03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 207 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Bio-Thera Solutions is the lead sponsor of 57 studies on the registry; 4 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
207 participants (actual)

Study arms

  • Experimental
    BAT2606 Injection

    PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

    Drug: Mepolizumab Injection (BAT2606 Injection)

  • Active comparator
    Mepolizumab Injection (EU-licensed Nucala®)

    PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

    Drug: Mepolizumab Injection (EU-licensed Nucala)

  • Active comparator
    Mepolizumab Injection (US-licensed Nucala®)

    PFS, Strength: 100 mg/1 mL, 100 mg, Subcutaneous injection.

    Drug: Mepolizumab Injection (US-licensed Nucala)

Interventions

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum blood concentration

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  2. AUC0-∞

    Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

Secondary outcomes

  1. AUC0-t

    Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  2. Tmax

    Observed time to peak concentration

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  3. t1/2

    Elimination half-life t1/2 = 0.693/λz

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  4. CL/F

    Total clearance rate, CL/F=Dose/AUC0-∞

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  5. Vd

    Apparent volume of distribution, Vd =Dose/(AUC0-∞ × λz)

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  6. 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

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  7. Adverse events

    AE and SAE

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

  8. Immunogenicity

    Anti-drug antibody (ADA) positivity, ADA titer and neutralizing antibody (NAb) positivity for ADA.

    Time frame: Day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57, 71, 85, 99, 113

07

Study locations

1 site
  • The First Hospital of Jilin University
    Jilin City, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in May 2023, 8 months.

Of 94 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 17. This study's 8 months is below that.

Counting every sponsor, half of 118 studies reached it within 11 months; a quarter within 4 and three quarters within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2022
First posted
Oct 12, 2022
StartActual
Sep 20, 2022
Primary completionActual
May 26, 2023
CompletionActual
Jun 19, 2023
Last update
Aug 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05576454
Lead sponsor
Bio-Thera Solutions
Responsible party
Sponsor
First posted
Oct 12, 2022
Start date
Sep 20, 2022
Primary completion
May 26, 2023
Completion
Jun 19, 2023
Last update
Aug 28, 2023

Study contacts

Yanhua Ding, PhD
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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