Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody … (NCT05027373) | Clinical Trial Compass
UnknownPhase 1
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
China34 participantsStarted 2021-08-13
Plain-language summary
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
* The body mass index (BMI) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
* Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3 months after finished the study
* Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
* Participants could communicate well with the researchers and compliance with the trial
Exclusion Criteria:
* Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
* Subjects who have or are currently suffering from any serious clinical diseases 3-6 months before screening, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
* Clinical laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.), auxiliary examinations (chest…