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

Beijing Bio-Fortune

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: Peginterferon 180 mcg single dose S.C.; Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01901198

921301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Human Serum Albumin/interferon alpha2a

Experimental group

Description:

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

Treatment:

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

Pegasys

Active Comparator group

Description:

Peginterferon 180 mcg single dose S.C.

Treatment:

Biological: Peginterferon 180 mcg single dose S.C.