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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.; Biological: Peginterferon 180 mcg single dose S.C.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Beijing Youan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Serum Albumin/interferon alpha2a; 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.; Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0
Active Comparator: Pegasys; Peginterferon 180 mcg single dose S.C.	Biological: Peginterferon 180 mcg single dose S.C.; Pegasys 180 mcg S.C. single dose on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events after single dose	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Bio-Fortune Ltd.
• Investigators: Principal Investigator: Ning Li, MD, Beijing YouAn Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon alpha-2
• Other Study ID Numbers: 921301