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Psoriatic ArthritisPhase 1NCT05332730

A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®

A Phase 1 study testing BAT2506 injection, Simponi® (EU commercially available product) and Simponi® (US commercially available product) in people with Psoriatic Arthritis, run by Bio-Thera Solutions at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male… 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
Psoriatic Arthritis
What is being tested?
BAT2506 injection, Simponi® (EU commercially available product) and Simponi® (US commercially available product)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteChina
Study dates
1 Aug 2022to 10 Jul 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)Signed the ICF and fully understood the trial conduction, procedure and potential adverse reactions before included the trial;
  • 2)Able to complete the study in accordance with the requirements of the protocol;
  • 3)Subjects (including their partners) who are willing to refrain from pregnancy and will not donate sperm throughout the trial and within 6 months after the end of the study, and willing to take effective contraceptive method, see Appendix 4 for specific contraceptive methods;
  • 4)Healthy male subjects at age of 18-55 years with a body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and a body weight between 50 and 80 kg (inclusive);
  • 5)Subjects with normal physical examination and vital signs or non-clinically significant abnormalities.
  • Subjects with normal abdominal color Doppler ultrasound, laboratory tests and other examination results or non-clinically significant abnormalities.

Who cannot join

  • 1)Subjects who smoked more than 5 cigarettes every day within 3 months prior to the trial;
  • 2)Subjects with a history of allergies to the study drug, or subjects with allergic constitution (allergic to a variety of drugs and foods);
  • 3)Subjects with a history of alcohol abuse (consuming 14 or more units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
  • 4)Subjects who donated blood within 3 months prior to screening or plan to donate blood during the study period;
  • 5)Subjects who had major injuries or underwent surgery or had fractures within 4 weeks prior to enrollment, or who are scheduled to undergo surgery during the study period;
  • 6)Subjects whose abnormalities in past medical history are clinically significant or other clinical findings suggest the following clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, blood, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases);
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  • 7)Subjects who suffered from malignant tumors (excluding those with basal cell carcinoma which has been surgically resected);
  • 8)Subjects with clinically significant chronic or acute infections at screening/enrollment, or with active infections, including acute and chronic infections and local infections (bacteria, viruses, parasites, fungi or other pathogens of opportunistic infectious diseases);
  • 9)Patients having a history of tuberculosis, or having latent tuberculosis infection or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis);
  • 10)Subjects who have contacted with tuberculosis patients or/and had symptoms and/or signs suspected of being tuberculosis within 3 months prior to screening ;
  • 11)Subjects who have used Simponi®, any anti-tumor necrosis factor (TNF-α) biologic, or have used any biologics or monoclonal antibodies within 6 months prior to enrollment ;
  • 12)Subjects who have used drugs (including but not limited to prescription drugs, traditional Chinese medicines, over-the-counter drugs, etc.) within 30 days prior to enrollment ;
  • 13)Subjects who have participated in other drug clinical trials within 3 months prior to enrollment;
  • 14)Have received live vaccine within 12 weeks prior to study administration or plan to receive live vaccine during study period; Have received inactivated vaccine (including COVID-2019 inactivated vaccine) within 2 weeks prior to administration or plan to receive inactivated vaccine during study period.
  • 15)Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/enrollment, which is judged to be a clinically significant abnormality;
  • 16)Subjects with clinically significant abnormalities in ECG;
  • 17)Positive hepatitis B surface antigen at screening [or negative hepatitis B surface antigen and meeting all three of the following: positive hepatitis B core antibody, negative hepatitis B surface antibody, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels exceed the normal quantification range]; or positive hepatitis C antibody, hepatitis C core antigen, HIV antigen/antibody, or positive syphilis spirochete antibody;
  • 18)Subjects with clinically significant abnormalities in frontal chest radiography;
  • 19)Those who have tested positive for enzyme-linked immunospot assay (T-SPOT. TB);
  • 20)Subjects who have taken any alcoholic products within 24 hours prior to the use of the study drugs;
  • 21)Those who have tested positive for drug abuse or have a history of drug abuse within past five years;
  • 22)Ineligible subjects based on investigator's judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

Other trials in China

About this study

Official title: A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi® in Healthy Chinese Male Subjects

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

Read the detailed description

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

The study planes to enroll 375 healthy male subjects who will be randomly assigned to the BAT2506 Injection group, Simponi® (EU-licensed) or Simponi® (US-licensed) groups in a 1:1:1 ratio to receive a single subcutaneous injection of 50 mg BAT2506 Injection or Simponi® (EU-licensed or US-licensed).

Being tested
BAT2506 injection, Simponi® (EU commercially available product), Simponi® (US commercially available product)
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT2506 injectionDrug

    50 mg, subcutaneous administration

  • Simponi® (EU commercially available product)Drug

    50 mg, subcutaneous administration

  • Simponi® (US commercially available product)Drug

    50 mg, subcutaneous administration

Study groups in NCT05332730
Study groupRoleWhat they receive
BAT2506ExperimentalBAT2506 injection, 50 mg, subcutaneous administration. Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark.
Receives: Drug: BAT2506 injection
Simponi® (EU commercially available product)Active comparator50 mg, subcutaneous administration Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark.
Receives: Drug: Simponi® (EU commercially available product)
Simponi® (US commercially available product)Active comparator50 mg, subcutaneous administration Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark.
Receives: Drug: Simponi® (US commercially available product)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Peak plasma concentration

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  2. AUC0-∞

    area under the drug concentration-time curve

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

Secondary outcomes (22)

  1. (AUC0-t)

    Area under the drug concentration-time curve from time 0 to the last quantifiable data point

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  2. temperature

    number of participants with abnormal temperature findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  3. pulse

    number of participants with abnormal pulse findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  4. blood pressure

    number of participants with abnormal blood pressure findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  5. skin mucosa

    number of participants with abnormal skin mucosa findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  6. lymph nodes

    number of participants with abnormal lymph nodes findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  7. head and neck

    number of participants with abnormal head and neck findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  8. chest

    number of participants with abnormal chest findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  9. abdomen

    number of participants with abnormal abdomen findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  10. spine/extremities

    number of participants with abnormal spine/extremities findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  11. heart rate

    number of participants with abnormal heart rate findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  12. PR Interval

    number of participants with abnormal PR Interval findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  13. RR Interval

    number of participants with abnormal RR Interval findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  14. QRS Interval

    number of participants with abnormal QRS Interval findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  15. QT Interval

    number of participants with abnormal QT Interval findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  16. QTc interval

    number of participants with abnormal QTc Interval findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  17. hematology,

    Number of participants with abnormal hematology findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  18. biochemistry

    Number of participants with abnormal biochemistry findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  19. coagulation routine

    Number of participants with abnormal coagulation routine findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  20. urinalysis

    Number of participants with abnormal urinalysis findings

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  21. Injection-site reaction Injection-site reaction

    Injection-site reaction Adverse events (AE), serious adverse events (SAE), etc.

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

  22. Adverse events (AE)

    Adverse events (AE), serious adverse events (SAE)

    Measured: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start1 Aug 2022
  3. Primary completion27 Jun 2023
  4. Study completion10 Jul 2023

Resources

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
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332730
Sponsor's protocol ID
BAT-2506-003-CR
Status last verified
Aug 2023
First submitted
3 Mar 2022
Last updated
28 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT2506 injection, Simponi® (EU commercially available product) and Simponi® (US commercially available product) in people with Psoriatic 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 22 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: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78). 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 NCT05332730.

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.

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