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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-07

Study Completion Date

2017-04-12

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human Serum Albumin/interferon alpha2b

Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C.

Group Type EXPERIMENTAL

Human Serum Albumin/interferon alpha2b

Intervention Type BIOLOGICAL

Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0

Pegasys

Peginterferon 180 μg single dose S.C.

Group Type ACTIVE_COMPARATOR

Peginterferon 180 μg single dose S.C.

Intervention Type BIOLOGICAL

Pegasys 180 mcg S.C. single dose on Day 0

Interventions

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Human Serum Albumin/interferon alpha2b

Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0

Intervention Type BIOLOGICAL

Peginterferon 180 μg single dose S.C.

Pegasys 180 mcg S.C. single dose on Day 0

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes