Psoriatic ArthritisPhase 1NCT04152759
Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects
A Phase 1 study testing Drug: BAT2506 injection Other Names: Simponi(EU-licensed) in people with Psoriatic Arthritis, run by Bio-Thera Solutions at 1 site in China.
Trial summary
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Drug: BAT2506 injection Other Names: Simponi(EU-licensed)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2019to 31 Dec 2020
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged18 and 50 years inclusive; BMI between 18 and 28 kg/m2 and body weight between 50 and 80 kg.
- Physical examinations and vital signs are normal or abnormal without clinical significance.
- Abdominal color Doppler ultrasound, laboratory tests, etc. are normal or abnormal without clinical significance.
Who cannot join
- Any current or history of severe allergic reaction to foods or drugs and History of allergy to study products.
- Having severe injuries or surgery or fractures within 4 weeks before enrollment,or to receive surgery during the study.
- Having clinically significantclinical history abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases).
- Having malignant tumor (excluding basal cell carcinoma who has undergone resection).
- Having clinically significant chronic or acute infections at screening/incorporation; or active infections,Includes acute and chronic infections as well as local infections (bacteria, viruses, parasites, fungi or other opportunities) Sexually infected pathogen).
- Having a history of tuberculosis or latent tuberculosis or clinical manifestations suspected of being tuberculosis(including But not limited to tuberculosis).
Show all 17Show fewer
- Having been exposed to tuberculosis or/and suspected tuberculosis symptoms and/or signs within 3 months before screening.
- Having used simponi,or any anti-tumor necrosis factor (TNF-α) biologic preparation or any biological products within 6 months before enrollment or monoclonal antibodies within a month.
- Having used drugs within 30 days before enrollment (including but not limited to prescription drugs, Chinese medicine, non-prescription drugs).
- Having vaccinated active / attenuated vaccine within 12 weeks before screening or planned to vaccinate active /attenuated vaccine the during the study.
- Having a history of hypertension or systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ at screening/inclusion90 mmHg, and it is judged abnormalities with clinical significance.
- Electrocardiogram (ECG) examination abnormalities with clinical significance;
- Having positive detection of golimumab anti-drug antibody (ADA) during screening.
- Chest orthotopic examination abnormalities with clinical significance.
- Tuberculosis enzyme-linked immunospot assay (T-SPOT. TB) positive test,
- Having any alcoholic products within 24 hours prior to the use of the study drug.
- A drug abuse test positive or a history of drug abuse over the past five years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Single-dose, 2-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2506 Injection vs Simponi in Healthy Chinese Male Subjects
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two 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.
Read the detailed description
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two 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
- Psoriatic Arthritis
- Being tested
- Drug: BAT2506 injection Other Names: Simponi(EU-licensed)
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: BAT2506 injection Other Names: Simponi(EU-licensed)Drug
Also called BAT2506
Drug: BAT2506 injection Each subject will receive single subcutaneous injection of 50 mg BAT2506 Injection or Simponi(EU-licensed).
Other Names:
Simponi(EU-licensed)
| Study group | Role | What they receive |
|---|---|---|
| BAT2506 injection | Experimental | 50mg ；subcutaneous injection Receives: Drug: Drug: BAT2506 injection Other Names: Simponi(EU-licensed) |
| Sinponi(EU-licensed) | Active comparator | 50mg ；subcutaneous injection Receives: Drug: Drug: BAT2506 injection Other Names: Simponi(EU-licensed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Endpoint：AUC0-t
Pharmacokinetics Endpoint：AUC0-t
Measured: 0-71days
Pharmacokinetics Endpoint：Cmax
Pharmacokinetics Endpoint：Cmax
Measured: 0-71days
Secondary outcomes (1)
Pharmacokinetics Endpoint：AUC0-inf
Pharmacokinetics Endpoint：AUC0-inf
Measured: 0-71days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start9 Sep 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Psoriatic 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152759
- Sponsor's protocol ID
- BAT-2506-001-CR
- Status last verified
- Nov 2019
- First submitted
- 9 Sep 2019
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only one site study
Publications
Wu M, Sun J, Wu D, Xu J, Wei J, Wang Z, Yu J, Li S, Zhang H, Ding Y. A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects. Expert Opin Investig Drugs. 2021 Jan;30(1):77-83. doi: 10.1080/13543784.2021.1851364. Epub 2020 Nov 26.
PubMed 33241960
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Single-dose, 2-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2506 Injection vs Simponi in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT04152759
- Acronym / sponsor ID
- BAT-2506-001-CR
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Nov 2019 (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, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two 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.
Detailed description
It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two 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
- 2
| Arm | Type | Receives |
|---|---|---|
| BAT2506 injection | Experimental | Drug: Drug: BAT2506 injection Other Names: Simponi(EU-licensed)50mg ；subcutaneous injection |
| Sinponi(EU-licensed) | Active comparator | Drug: Drug: BAT2506 injection Other Names: Simponi(EU-licensed)50mg ；subcutaneous injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged18 and 50 years inclusive; BMI between 18 and 28 kg/m2 and body weight between 50 and 80 kg.
- Physical examinations and vital signs are normal or abnormal without clinical significance.
- Abdominal color Doppler ultrasound, laboratory tests, etc. are normal or abnormal without clinical significance.
Key exclusion criteria (17 listed)
- Any current or history of severe allergic reaction to foods or drugs and History of allergy to study products.
- Having severe injuries or surgery or fractures within 4 weeks before enrollment,or to receive surgery during the study.
- Having clinically significantclinical history abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases).
- Having malignant tumor (excluding basal cell carcinoma who has undergone resection).
- Having clinically significant chronic or acute infections at screening/incorporation; or active infections,Includes acute and chronic infections as well as local infections (bacteria, viruses, parasites, fungi or other opportunities) Sexually infected pathogen).
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 |
|---|---|---|
| Drug: BAT2506 injection Other Names: Simponi(EU-licensed)Also: BAT2506Drug: BAT2506 injection Each subject will receive single subcutaneous injection of 50 mg BAT2506 Injection or Simponi(EU-licensed). Other Names: Simponi(EU-licensed) | Drug | BAT2506 injection, Sinponi(EU-licensed) |
Primary outcome
Pharmacokinetics Endpoint：AUC0-t
Time frame: 0-71days
Pharmacokinetics Endpoint：AUC0-t
Pharmacokinetics Endpoint：Cmax
Time frame: 0-71days
Pharmacokinetics Endpoint：Cmax
1 secondary outcome
Pharmacokinetics Endpoint：AUC0-inf
Time frame: 0-71days
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 1 Apr 2024.
- Derived from this study: PubMed 33241960Wu M, Sun J, Wu D, Xu J, Wei J, Wang Z, Yu J, Li S, Zhang H, Ding Y. A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects. Expert Opin Investig Drugs. 2021 Jan;30(1):77-83. doi: 10.1080/13543784.2021.1851364. Epub 2020 Nov 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drug: BAT2506 injection Other Names: Simponi(EU-licensed) 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 3 inclusion and 17 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 1 Apr 2024. 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：AUC0-t (time frame: 0-71days). 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 NCT04152759, 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 1 Apr 2024.