chronic spontaneous urticaria, etc.
Conditions
Interventions
Cohort 1:25 mg QX013N injection or matched placebo, s.c.
Cohort 2:75 mg QX013N injection or matched placebo, s.c.
Cohort 3:150 mg QX013N injection or matched placebo, s.c.
Cohort 4:300 mg QX013N injection or matched placebo, s.c.
Cohort 5:600 mg QX013N injection or matched placebo, s.c.
Cohort 6:600 mg QX013N injection or matched placebo, i.v. drips
Sponsors
Affiliated Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.18-55 years old by the time signing an informed consent form (ICF), male or female. 2.Requirement for male weight=50 kg and =100 kg, for female weight=45 kg and =100 kg; 18.5=BMI<28 kg/m2. 3.Diagnosed to be qualified after systematic examination, such as physical examination, experimental tests(including blood routine test, blood chemistry panel, urine routine test, coagulation routine test, thyroid function test, humoral immunity test, infectious diseases test), 12 lead ECG examination, abdomen ultrasonography examination, underwent anteroposterior and lateral position X-ray examination. 4.Men or women of child-bearing potential promise to use a contraceptive method during the whole study and until 6 months after the end of the study. 5.With ability to understand objectives, type, method and all the potential adverse reactions, and willing to be an experimental subject of QX013N, and willing and able to sign an informed consent form (ICF). 6.Willing to comply with the study procedure until the end of the study.
Exclusion criteria
Exclusion criteria: 1.History of severe allergic to drugs or food may bring high risk to subjects, or may allergic to pharmaceutical ingredients of investigational medicinal product (IMP), as judged by investigator. 2.Pregnant or breast-feeding women. 3.History of active or suspected immunosuppressive condition(idiopathic, or secondary condition) with incompletely control within 6 months before randomization, despite the infection resolution, such as invasive occasional infectious diseases (eg, aspergillosis, coccidiodomycosis, histoplasmosis, listeriosis, pneumocystosis, or TB, etc.), or unusually frequent recurrent or long-term infection, or herpes virus infection (such as herpes zoster infection or varicella-zoster virus infection, etc.) within 3 months before the screening visit, or diagnosed as high infection risk(eg, patients with leg ulcer, indwelling urinary catheter, persistent or recurrent chest infection, or long-term bedridden or sit on wheelchair), or presence of primary immunodeficiency diseases, as per investigator’s judgement. 4.History of active TB infection, or diagnosed as active TB infection, or latent TB infection, or suspected TB infection at the screening visit. 5.Presence of the following infection at the screening visit: a.Presence of active HBV infection(positive HBsAg, or negative HBsAg and positive HBcAb plus HBV DNA above normal range). b.Presence of active HCV infection(positive antibody to HCV). c.Positive syphilis testing(positive treponemal antibody). d.History of HIV infection, or presence of positive antibody to HIV. 6.Blood donation=400 mL or blood loss equivalent to 400 mL within 4 weeks before the screening visit, or history of receiving a blood transfusion within 8 weeks before the screening visit. 7.History of treatment with a live vaccine or an attenuated vaccine within 3 months before the screening visit, or planned for a live vaccine or an attenuated vaccine during the study period. 8.Treatment with systemic traditional Chinese medicine(TCM) therapies or prescription drugs within 4 weeks before medication, or dietary supplements, or topical TCM therapies or non-prescription drugs within 2 weeks before medication. 9.With abnormal results as one the following criteria at the screening visit: a.AST/ALT/Total bilirubin>1.2 ULN. d.Diagnosed with other abnormal results that may present unacceptable risk to subjects, in the opinion of investigator. (Retest is permitted, but only once within the screening period, and medication treatment is not permitted before retest.) 10.Diagnosed with abnormal medical conditions or experimental test results that with clinical significance or may interference with study results, in the judgement of investigator, such as, but bot limited to, the following: with diseases or disorders in cardiovascular system, kidney, hepatic, gastrointestinal tract(e.g., dysphagia, gastrointestinal ulcerations), pulmonary system, hematological system, metabolic disease, nervous system, endocrine disease, ophthalmology (e.g., conjunctivitis, keratitis), gynecology(only for female), skeletal system, or suffered by infectious disease. 11.History of drug abuse within 5 years before the screening visit, or patients with positive urine addictive screening test result at the screening visit. 12.History of alcohol abuse (defined as>2 units per day, or >14 units per week, 1 unit alcohol equals to 360 mL beer or 45 mL 40% wine or 150 mL red wine) or drug abuse within 12 months before randomization. 13.Treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration;Anti-QX013N antibody; | — |
Countries
China
Contacts
Public ContactWang Ying
Affiliated Hangzhou First People's Hospital
Outcome results
None listed