Status:
COMPLETED
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers
Lead Sponsor:
Beijing Bio-Fortune Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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
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 Pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01901198
Start Date
April 1 2013
End Date
December 1 2013
Last Update
November 17 2014
Active Locations (1)
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1
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069