Herpes Zoster
Conditions
Keywords
Peginterferon α1b for Injection
Brief 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.
Detailed description
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.
Interventions
DRUGPEGIFNα1b
100μg/vial
DRUGPlacebo
0.5ml/vial
Sponsors
Shanghai Institute Of Biological Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | receive PEGIFNα1b (day 1) to day 28 | The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured. |
| ADA | Receive PEGIFNα1b/placebo (day 1) to day21. | ADA in plasma of participants for immunogenicity assessments. |
| Nab | Receive PEGIFNα1b/placebo (day 1) to day21. | Nab in plasma of participants for immunogenicity assessments. |
| λz | Receive PEGIFNα1b/placebo (day 1) to day 15. | Pharmacokinetic assessments |
| Tmax | Receive PEGIFNα1b/placebo (day 1) to day 15. | Pharmacokinetic assessments |
| Peak Plasma Concentration (Cmax) | Receive PEGIFNα1b/placebo (day 1) to day 15. | Pharmacokinetic assessments |
| Area under the plasma concentration versus time curve (AUC) | Receive PEGIFNα1b/placebo (day 1) to day 15 | Pharmacokinetic assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Neopterin | Receive PEGIFNα1b/placebo (day 1) to day15 | Plasma concentration of 2',5'-OAS(Type I,II), Neopterin |
Countries
China
Outcome results
None listed