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

• Status: Completed
• Trial end date: 2021-04-19
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bio-Thera Solutions
• Treatments: Ustekinumab

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.