A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorRemeGen Co., Ltd.

About this trial

This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.

Eligibility criteria

Qualifiers

18-50 years old at the time of signing the informed consent form,gender is unlimited;

Male Weight 55-70 kg, female Weight 50-65 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values);

Physical examination, vital signs, chest radiographs, ECG, epidemiologic tests, routine blood tests, blood biochemistry, lipids, urinalysis, and coagulation are normal,or abnormal by the investigator as having no clinical significance;

Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete all trial procedures according to the trial requirements.

Disqualifiers

Site staff and family members directly involved in the trial; or sponsor staff and family members directly involved in the implementation of the trial;

History of any of any nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood and lymphatic system, skeletal muscle system, immune system, metabolic system disease, or other diseases that are not suitable for clinical trials (such as mental history, malignant tumors, etc.);

History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of lymphoproliferative disease;

History of abnormal bleeding or coagulation disorders (such as prone to bruising, gingival bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, heavy menstruation leading to anemia within 1 year, postpartum hemorrhage, vitamin K deficiency, hemorrhagic disease caused by acquired coagulation factor antibodies, bleeding after trauma or surgery, etc.) , or abnormal laboratory coagulation parameters, or an inherited tendency to bleed or have coagulation dysfunction, or have a history of blood clots or bleeding, or require long-term use of anticoagulants or antiplatelet aggregation drugs;

Trial design

Treatments tested in this trial

  • Telitacicept Pre-filled Injection 80mg
  • Telitacicept Freeze-dried powder Injection 80mg

Treatment groups

248 Participants
are divided into 2 treatment groups

Sponsors and collaborators