Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects

NCT ID: NCT04371185

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-08
• Study Completion Date: 2021-04-19

Brief Summary

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).

Detailed Description

The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the similarity of the pharmacokinetics of the three 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

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BAT2206 injection

45mg; subcutaneous injection

Group Type: EXPERIMENTAL

BAT2206

Intervention Type: DRUG

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Stelara(US-licensed)

45mg; subcutaneous injection

Group Type: ACTIVE_COMPARATOR

Stelara(US-licensed)

Intervention Type: DRUG

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Stelara(EU-licensed)

45mg; subcutaneous injection

Group Type: ACTIVE_COMPARATOR

Stelara(EU-licensed)

Intervention Type: DRUG

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Interventions

BAT2206

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Intervention Type: DRUG

Stelara(US-licensed)

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Intervention Type: DRUG

Stelara(EU-licensed)

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Ustekinumab; Ustekinumab

Eligibility Criteria

Inclusion Criteria

• Chinese male healthy subjects aged from 18 to 55 years (including the boundary value)；
• BMI between 18-28kg/m2 (including boundary value) and body weight between 55-85kg;
• Normal physical examination results or abnormal with no clinical significance according to the doctor's judgment;
• The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study, and voluntarily adopts effective contraceptive measures;
• Sign the informed consent before joining the study, and fully understand the content, process and possible risks;
• Willing and able to comply with the visits and treatments of the trial protocol.

Exclusion Criteria

• Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases with clinical significance within one year prior to screening;
• ECG is abnormal and has clinical significance (judged by the investigator);
• With active infection within two months before screening, including acute and chronic infection and local infection;
• Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive;
• Having taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days before screening (or within 5 half-lives of the above drugs, whichever is longer);
• Having participated in drug clinical trials within 3 months before the study administration, or planning to participate in other drug clinical trials during the study period;
• Acute disease occurred or with concomitant medication from the screening to use of the study drug; major injury or surgery or fracture occurred within 4 weeks before enrollment, or surgery was planned during the study;
• Having used ustekinumab, anti-tumor necrosis factor (TNF) or interleukin (IL) targeting agents, or having used any biological products or monoclonal antibodies within 3 months before screening;
• Any immunoglobulin biologicals were used one year prior to screening;
• Having received within 12 weeks prior to initiating treatment or planning to receive live virus or live vaccines during the study;
• Suspected or confirmed as allergic constitution (allergic to variety of drugs or food), or allergic to ustekinumab, or severe allergic or allergic reaction to monoclonal antibody;
• Blood donation or massive blood loss (> 450 ml) within 3 months before using the study drug, or planning to donate blood during the study, or having received blood transfusion within 8 weeks before screening;
• Employees or relatives of all investigators, clinical centers, clinical research organizations or sponsors cannot be included in the group;
• Subjects considered unsuitable by the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bio-Thera Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding

Role: PRINCIPAL_INVESTIGATOR

the First Hospital of Jinlin University

Locations

The First Hospital of Jilin University

Jilin, , China

Countries

China

References

Wu M, Li X, Yang D, Wang M, Zhang H, Li C, Mai J, Yang L, Qi Y, Yu JC, Yang X, Wang Z, Gu C, Ding Y. Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. BioDrugs. 2023 Jan;37(1):89-98. doi: 10.1007/s40259-022-00563-5. Epub 2022 Nov 22.

Reference Type: DERIVED

PMID: 36417156 (View on PubMed)

Other Identifiers

BAT-2206-001-CR

Identifier Type: -

Identifier Source: org_study_id