Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.

Detailed Description
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This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.

Official Title
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A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Healthy Chinese Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: Human Serum Albumin/interferon alpha2b
* Biological: Peginterferon 180 μg single dose S.C.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be healthy males or females between 18 to 45 years old, inclusive Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg Exclusion Criteria: History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases Female subjects who are pregnant or breastfeeding Any previous treatment with Human Albumin Interferon fusion protein

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Serum Albumin/interferon alpha2b<br>Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. | Biological: Human Serum Albumin/interferon alpha2b<br>* Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0<br>|
| Active Comparator: Pegasys<br>Peginterferon 180 μg single dose S.C. | Biological: Peginterferon 180 μg single dose S.C.<br>* Pegasys 180 mcg S.C. single dose on Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events after single dose | Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of interferon after single dose | Peak plasma concentration(Cmax) | 4 weeks | 
| Pharmacokinetics of interferon after single dose | Area under the plasma concentration versus time curve (AUC) | 4 weeks | 
| Plasma concentration of Neopterin after single dose | Plasma concentration of Neopterin after single dose | 4 weeks | 
| Pharmacokinetics of interferon after single dose | Peak time(Tmax) | 4 weeks | 
| Pharmacokinetics of interferon after single dose | Half-life period(T1/2) | 4 weeks |