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> Record changed: 2026-10-13

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

NCT05332730

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

Participants

375

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

Lead sponsor

Bio-Thera Solutions

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

Start date

2022-08-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Title and summary

**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 subjects.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Dates

**Completion date**

2023-07-10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**First posted**

2022-04-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Registry last updated**

2023-08-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Primary completion date**

2023-06-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Start date**

2022-08-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Size and sites

**Actual participants**

375

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Participants**

375

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Randomisation ratio**

1:1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Sponsor and oversight

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Lead sponsor**

Bio-Thera Solutions

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Identifiers

**Registry ID**

NCT05332730

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**ClinicalTrials.gov ID**

NCT05332730

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Outcomes

### Primary outcomes

1. Cmax  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Peak plasma concentration
2. AUC0-∞  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
area under the drug concentration-time curve

### Secondary outcomes

1. (AUC0-t)  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Area under the drug concentration-time curve from time 0 to the last quantifiable data point
2. temperature  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal temperature findings
3. pulse  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal pulse findings
4. blood pressure  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal blood pressure findings
5. skin mucosa  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal skin mucosa findings
6. lymph nodes  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal lymph nodes findings
7. head and neck  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal head and neck findings
8. chest  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal chest findings
9. abdomen  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal abdomen findings
10. spine/extremities  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal spine/extremities findings
11. heart rate  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal heart rate findings
12. PR Interval  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal PR Interval findings
13. RR Interval  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal RR Interval findings
14. QRS Interval  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal QRS Interval findings
15. QT Interval  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal QT Interval findings
16. QTc interval  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
number of participants with abnormal QTc Interval findings
17. hematology,  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Number of participants with abnormal hematology findings
18. biochemistry  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Number of participants with abnormal biochemistry findings
19. coagulation routine  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Number of participants with abnormal coagulation routine findings
20. urinalysis  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Number of participants with abnormal urinalysis findings
21. Injection-site reaction Injection-site reaction  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Injection-site reaction Adverse events (AE), serious adverse events (SAE), etc.
22. Adverse events (AE)  
Timeframe: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78  
Adverse events (AE), serious adverse events (SAE)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Eligibility

**Sex**

Male

**Age groups**

Adults

**Minimum age**

18 Years

**Maximum age**

55 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- 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.

### Exclusion criteria

- 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);
- 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Sites

- The First Bethune Hospital of Jilin UniversityChangchun, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05332730)

## Related records

### Drugs (2)

- [Golimumab](https://trialight.com/data/asset/golimumab-029e0cce-9d8f-4121-b835-6c4aa307913c.md)
- [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md)

### Collaborators (1)

- The First Hospital of Jilin University

### Lead sponsors (1)

- [Bio-Thera Solutions](https://trialight.com/data/company/bio-thera-solutions-f0083db2-9bf0-4f0c-af64-1650c0ec26d2.md)

### Conditions (1)

- [Psoriatic arthritis](https://trialight.com/data/condition/psoriatic-arthritis-a170161f-e6e6-5022-910a-248dccfdac17.md) Primary condition

### Targets (1)

- [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md)

---

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