The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.
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 alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b 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
34
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0
Pegasys 180 mcg S.C. single dose on Day 0
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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.
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Peak plasma concentration(Cmax)
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Area under the plasma concentration versus time curve (AUC)
Time frame: 4 weeks
Plasma concentration of Neopterin after single dose
Plasma concentration of Neopterin after single dose
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Peak time(Tmax)
Time frame: 4 weeks
Pharmacokinetics of interferon after single dose
Half-life period(T1/2)
Time frame: 4 weeks
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