Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers

Study Overview
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Brief Summary
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This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.

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 alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a 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 alpha2a Fusion Protein in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.
* Biological: Peginterferon 180 mcg 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 Other protocol-defined inclusion/exclusion criteria may apply

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 alpha2a<br>Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. | Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.<br>* Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0<br>|
| Active Comparator: Pegasys<br>Peginterferon 180 mcg single dose S.C. | Biological: Peginterferon 180 mcg 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 |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of interferon after single dose |  | 4 weeks | 
| Plasma concentration of Neopterin after single dose |  | 4 weks |