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

Phase 1CompletedNCT01901198

Beijing Bio-Fortune Ltd.34 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

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

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

Peginterferon 180 mcg single dose S.C.BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Number of participants with adverse events after single dose

Time frame: 4 weeks

Secondary Outcomes

Plasma concentration of interferon after single dose

Time frame: 4 weeks

Plasma concentration of Neopterin after single dose

Time frame: 4 weks

Data from ClinicalTrials.gov

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