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

NCT ID: NCT01901198

Last Updated: 2014-11-17

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

2013-04-30

Study Completion Date

2013-12-31

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.

Conditions

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Healthy Volunteers

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 alpha2a

Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.

Group Type EXPERIMENTAL

Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.

Intervention Type BIOLOGICAL

Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0

Pegasys

Peginterferon 180 mcg single dose S.C.

Group Type ACTIVE_COMPARATOR

Peginterferon 180 mcg 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 alpha2a 300-1200 mcg single dose S.C.

Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0

Intervention Type BIOLOGICAL

Peginterferon 180 mcg 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

Sponsors

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Beijing Bio-Fortune Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ning Li, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Locations

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Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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921301

Identifier Type: -

Identifier Source: org_study_id