Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein 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 alpha2b Fusion Protein in Healthy Chinese Volunteers
1 other identifier
interventional
34
1 country
1
Brief Summary
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2016
CompletedFirst Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2017
CompletedMay 8, 2017
April 1, 2017
4 months
May 20, 2016
May 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events after single dose
Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events.
4 weeks
Secondary Outcomes (5)
Pharmacokinetics of interferon after single dose
4 weeks
Pharmacokinetics of interferon after single dose
4 weeks
Plasma concentration of Neopterin after single dose
4 weeks
Pharmacokinetics of interferon after single dose
4 weeks
Pharmacokinetics of interferon after single dose
4 weeks
Study Arms (2)
Human Serum Albumin/interferon alpha2b
EXPERIMENTALHuman Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C.
Pegasys
ACTIVE COMPARATORPeginterferon 180 μg single dose S.C.
Interventions
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meixia Wang, Professor
Beijing YouAn Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
May 24, 2016
Study Start
April 7, 2016
Primary Completion
August 2, 2016
Study Completion
April 12, 2017
Last Updated
May 8, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share