Status:
COMPLETED
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects
Lead Sponsor:
Bio-Thera Solutions
Conditions:
Psoriasis
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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-lice...
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 pharmacokineti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2021
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04371185
Start Date
August 8 2020
End Date
April 19 2021
Last Update
September 13 2021
Active Locations (1)
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1
The First Hospital of Jilin University
Jilin, China