Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects

Study Overview
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Brief Summary
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This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.

Official Title
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A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Peginterferon alfa
* Drug: Peginterferon alfa 2a
* Drug: Peginterferon alfa-2a
* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Age between 18 and 45, inclusive Body mass index(BMI)between 19 and 26, inclusive Sign informed consent Exclusion Criteria: Women of pregnant or lactation Known hypersensitivity to interferon or any other components of the study drug History of mental disease or genetic disease History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant Significant disease in heart, liver, kidney, lung or any other major organs Alcoholic, smokers or drug abusers Blood donation, or massive blood loss due to injury or surgery within 3 months Other conditions which in the opinion of the investigator preclude enrollment into the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: Peginterferon alfa<br>* s,c, 45mcg of Ypeginterferon alfa-2a<br>|
| Other: Arm 2<br> | Drug: Peginterferon alfa 2a<br>* s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.<br>|
| Other: Arm 3<br> | Drug: Peginterferon alfa-2a<br>* s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.<br>|
| Other: Arm 4<br> | Drug: Peginterferon alfa-2a<br>* s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring interferon levels in blood samples |  | from 0 to 408 hours following injection | 
| Different blood interferon biomarkers (such as 2,5-OAS, neopterin) |  | from 0 to 408 hours following injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | up to 3 weeks following injection | 
| Anti-interferon antibody |  | baseline and week 2 after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peginterferon, Healthy subject, Pharmacokinetics, Pharmacodynamics, Safety