a clinical trial of pegifnα1b in chinese healthy adults

Conditions: Herpes Zoster

Summary: this is a phase i，randomized, double-blind, placebo controlled,dose escalated,single administrated clinical trial in chinese healthy adult's volunteers. in the trial, it is planned to enroll 50 subjects, randomized to 5 dosage groups to receive the test drug and the placebo control.

this study is a randomized, double-blind, placebo-controlled, dose-escalation, single-dose phase i clinical study, including safety tolerability assessment, pharmacokinetic studies and immunogenicity studies, to evaluate the expression level of mrna in whole blood of 2',5'-oligoadenylate synthetase, as well as the level of neopterin (ntp) in serum.

Eligibility criteria:
inclusion criteria: * must agree to and voluntarily sign a written informed consent prior to the study. * must be healthy males or females. * between 18 to 70 years old, inclusive. * must have a body mass index (bmi) of 19 to 26 kg/m2, inclusive, and male subject must have a minimum body weight of 50.0 kg,female subject must have a minimum body weight of 45kg. exclusion criteria: * history of allergic or anaphylactic reactions or known allergy to any component of interferon medication including the study drug. * having abnormality in physical examination,vital signs, electrocardiogram,eye,skin(e.g., psoriasis,sarcoidosis) within screening and the abnormality is considered clinically significant as determined by the investigator. * laboratory values (platelet, hemoglobin or neutrophils)that were outside the normal range，alt，ast or tg\>1.5 fold normal range，positive test result for pregnancy,hepatitis b surface antigen(hbsag) ,hepatitis c antibody (hcv ab),treponema pallidum antibody or human immunodeficiency virus antibody(hiv ab), thyroid function abnormal within screening. * having any ischemic disease,autoimmune disease,infectious disorders,history of neuropsychiatric disease (e.g., epilepsy,depression,suicidal behavior). * history of any disease (gastrointestinal tract,renal,hepatic,neurologic,hematologic,endocrinologic, tumor, pulmonary, cardiovascular and/or other major disease), or organ transplantation within 6 months prior to screening. * unlikely to comply with unified diet or having difficulty to swallow. * treatment with any medication( prescription/nonpreserip drugs/vitamins/herbs ) within 30 days prior to screening. * history of alcohol abuse (more than 14 units of alcohol per week, one unit of alcohol equals 360ml beer or 150ml wine or 45ml strong drinks containing 40% alcohol) within 3 months prior to screening or a positive screen test for presence for alcohol at screening or into hospital. * consuming any special diet(including dragon fruit,mango,grapefruit,etc. ) or doing strenuous exercise within 2 weeks prior to screening. consuming alcohol or caffeine containing products(e.g., coffee,tea, coco,chocolate ) within 48 hours of dosing. intaking any products can affecting drug absorption,distribution,excretion,metabolism. * regular smoking with consumption ≥ 5 cigarettes per day winthin 3 months prior to screening. * treatment with any interferon product within 6 months prior to screening. * participation in any other medication or device study within 3 months prior to screening. * history of drug (morphine,marihuana,methamphetamine,dimethylamphetamine,ketamine,etc.) abuse or a positive screen test for presence for drugs. * having donated or lost 200 ml or more of blood within 3 months prior to screening or plan to donate blood throughout the study and within 3 months after the study. * lactating mothers,male subjects(or pairs) and female subjects have child-bearing/sperm or egg donation plan from 30 days before study to 3 months after study while unwill to practice effective birth control throughout the study. * history of blood or needle phobia. * driving or operating delicated machinery throughout the study. * investigator discretion as to unsuitability

Keywords: peginterferon α1b for injection