Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects

Korábbi kezelés

• Use of IL-17 or other monoclonal antibodies in the last 6 months;
• Positive for anti-IL-17 antibodies at screening;
• With active infection at screening or have been hospitalized for a serious infection during the 8 months prior to screening or use of antibiotics within 2 weeks of enrollment;
• Use drug treatment (including prescription drugs, over-the-counter drugs, health product etc.) within 14 days before screening;
• Surgery within 2 months prior to screening; or plan to have surgery during the study period;.
• Have received live vaccines within 6 months prior to screening, or have used any vaccines within 4 weeks prior to screening, or plan to be vaccinated during the trial.;
• Blood donation or massive blood loss (> 400 ml) within 3 months or blood loss (> 200 ml) within 1 month before signing the informed consent; or plan to donate blood during the trial;
• Acute disease occurred or with concomitant medication from the screening to use of the study drug.;

Más betegség

• Evidence of tuberculosis infection;
• Anti-IL-17 antibody active ingredient, excipients or latex allergy;
• With severe bleeding factors that affect venous blood collection or unwilling to undergo venipuncture;
• History of malignant neoplasms；
• Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive; .
• Have a history of drug or substance abuse before screening; or positive drug abuse test results on the day of check-in;
• Other conditions considered inappropriate to be included in this study.

Laborértékek

• Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, mental or cardiovascular and cerebrovascular diseases) with clinical significance;

Egyéb

• Have pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study;

• Able to understand and sign informed consent form；
• Healthy men 18-50 years of age at time of consent；
• Body weight of ≥50 kg and ≤ 80 kg and BMI ≥19 and ≤ 26 kg/m2.