A Phase 1 interventional study of Human Serum Albumin/interferon alpha2b and Peginterferon 180 μg single dose S.C. in Healthy, sponsored by Tianjin SinoBiotech Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-08.
Sponsored by Tianjin SinoBiotech Ltd. · Phase 1, Interventional, and Treatment
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.
Tianjin SinoBiotech Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C.
Biological: Human Serum Albumin/interferon alpha2b
Peginterferon 180 μg single dose S.C.
Biological: Peginterferon 180 μg single dose S.C.
Drug pages: Albumins human · Interferon-alpha2b
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Albumins human · Interferon-alpha2b
Tianjin SinoBiotech Ltd.