Clinical Trials/NCT05332730

NCT05332730

Completed

Phase 1

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

Bio-Thera Solutions1 site in 1 country375 target enrollmentAugust 1, 2022

ConditionsPsoriatic Arthritis

InterventionsBAT2506 injection Simponi® (EU commercially available product)Simponi® (US commercially available product)

DrugsBAT2506 injection Simponi® (EU commercially available product)Simponi® (US commercially available product)

Overview

Phase: Phase 1
Intervention: BAT2506 injection
Conditions: Psoriatic Arthritis
Sponsor: Bio-Thera Solutions
Enrollment: 375
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

July 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bio-Thera Solutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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 ;

Arms & Interventions

BAT2506

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.

Intervention: BAT2506 injection

Simponi® (EU commercially available product)

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.

Intervention: Simponi® (EU commercially available product)

Simponi® (US commercially available product)

Intervention: Simponi® (US commercially available product)

Outcomes

Primary Outcomes

Cmax

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

Peak plasma concentration

AUC0-∞

Time Frame: 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

PR Interval(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)
abdomen(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
spine/extremities(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
QRS Interval(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
(AUC0-t)(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)
lymph nodes(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
head and neck(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
chest(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
QT Interval(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
hematology,(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
heart rate(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
QTc interval(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
coagulation routine(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
RR Interval(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
biochemistry(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
urinalysis(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
Injection-site reaction Injection-site reaction(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)
Adverse events (AE)(on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78)