NCT05332730

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

March 3, 2022

Last Update Submit

August 25, 2023

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Peak plasma concentration

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

  • AUC0-∞

    area under the drug concentration-time curve

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

Secondary Outcomes (22)

  • (AUC0-t)

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

  • temperature

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

  • pulse

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

  • blood pressure

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

  • skin mucosa

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

  • +17 more secondary outcomes

Study Arms (3)

BAT2506

EXPERIMENTAL

BAT2506 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.

Drug: BAT2506 injection

Simponi® (EU commercially available product)

ACTIVE COMPARATOR

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.

Drug: Simponi® (EU commercially available product)

Simponi® (US commercially available product)

ACTIVE COMPARATOR

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.

Drug: Simponi® (US commercially available product)

Interventions

BAT2506 injectionDRUG

50 mg, subcutaneous administration

BAT2506
Simponi® (EU commercially available product)DRUG

50 mg, subcutaneous administration

Simponi® (EU commercially available product)
Simponi® (US commercially available product)DRUG

50 mg, subcutaneous administration

Simponi® (US commercially available product)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Details(1) healthy subjects are free from underlying diseases and concomitant medications, so that the PK parameters of all individuals tend to be more consistent; (2) the inclusion of male subjects can exclude the influence of female menstrual cycle, thereby reducing the interference from the fluctuations of PK parameters among subjects. Under the premise of fully considering the safety of the subjects, this study chooses healthy male subjects as the test population.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • )Signed the ICF and fully understood the trial conduction, procedure and potential adverse reactions before included the trial;
  • )Able to complete the study in accordance with the requirements of the protocol;
  • )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;
  • )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);
  • )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.

You may not qualify if:

  • )Subjects who smoked more than 5 cigarettes every day within 3 months prior to the trial;
  • )Subjects with a history of allergies to the study drug, or subjects with allergic constitution (allergic to a variety of drugs and foods);
  • )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);
  • )Subjects who donated blood within 3 months prior to screening or plan to donate blood during the study period;
  • )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;
  • )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);
  • )Subjects who suffered from malignant tumors (excluding those with basal cell carcinoma which has been surgically resected);
  • )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);
  • )Patients having a history of tuberculosis, or having latent tuberculosis infection or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis);
  • )Subjects who have contacted with tuberculosis patients or/and had symptoms and/or signs suspected of being tuberculosis within 3 months prior to screening ;
  • )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 ;
  • )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 ;
  • )Subjects who have participated in other drug clinical trials within 3 months prior to enrollment;
  • )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.
  • )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;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

golimumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yanhua Ding, Doctor

    The First Hospital of Jinlin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

April 18, 2022

Study Start

August 1, 2022

Primary Completion

June 27, 2023

Study Completion

July 10, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)