A Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I，Randomized, Double-blind，Placebo Controlled，Dose Escalated, Single Adminstrated Clinical Trial of PEGIFNα1b in Chinese Healthy Adults

Conditions
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Herpes Zoster

Intervention / Treatment
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* Drug: PEGIFNα1b
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEGIFNα1b 1.5 μg/kg<br>8 randomized participants receive one dose PEGIFNα1b 1.5 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered | Drug: PEGIFNα1b<br>* 100μg/vial<br>Drug: Placebo<br>* 0.5ml/vial<br>|
| Experimental: PEGIFNα1b 3.0 μg/kg<br>8 randomized participants receive one dose PEGIFNα1b 3.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered | Drug: PEGIFNα1b<br>* 100μg/vial<br>Drug: Placebo<br>* 0.5ml/vial<br>|
| Experimental: PEGIFNα1b 5.0μg/kg<br>8 randomized participants receive one dose PEGIFNα1b 5.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered | Drug: PEGIFNα1b<br>* 100μg/vial<br>Drug: Placebo<br>* 0.5ml/vial<br>|
| Experimental: PEGIFNα1b 6.0 μg/kg<br>8 randomized participants receive one dose PEGIFNα1b 6.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered | Drug: PEGIFNα1b<br>* 100μg/vial<br>Drug: Placebo<br>* 0.5ml/vial<br>|
| Experimental: PEGIFNα1b 7.0 μg/kg<br>8 randomized participants receive one dose PEGIFNα1b 7.0 μg/kg, 2 randomized participants receive one dose placebo, subcutaneous administered | Drug: PEGIFNα1b<br>* 100μg/vial<br>Drug: Placebo<br>* 0.5ml/vial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | The number of adverse events associated with the PEGIFNα1b/placebo will be collected and measured. | receive PEGIFNα1b (day 1) to day 28 | 
| λz | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15. | 
| Tmax | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15. | 
| Peak Plasma Concentration (Cmax) | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15. | 
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetic assessments | Receive PEGIFNα1b/placebo (day 1) to day 15 | 
| ADA | ADA in plasma of participants for immunogenicity assessments. | Receive PEGIFNα1b/placebo (day 1) to day21. | 
| Nab | Nab in plasma of participants for immunogenicity assessments. | Receive PEGIFNα1b/placebo (day 1) to day21. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Neopterin | Plasma concentration of 2',5'-OAS(Type I,II), Neopterin | Receive PEGIFNα1b/placebo (day 1) to day15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peginterferon α1b for Injection