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Pharmacokinetics and Pharmacodynamics of Novel Long-Acting Ropeginterferon Alfa-2b in Healthy Chinese Subjects
- Source :
- Advances in Therapy. 38:4756-4770
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- Ropeginterferon alfa-2b is a novel mono-pegylated human recombinant interferon (IFN) with the addition of N-terminal proline covalently attached by a 40-kDa polyethylene (peg) moiety. The present study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) profiles and safety of the product in healthy Chinese. Forty subjects were enrolled and treated with a single subcutaneous injection of either 180 mcg peg-IFN alfa-2a or 90, 180, and 270 mcg ropeginterferon alfa-2b. The mean Tmax of ropeginterferon alfa-2b was 92–141 h and the elimination half-life was 78–129 h. Dose-related, non-proportional increase in ropeginterferon alfa-2b exposure was observed, which was higher than for peg-IFN alfa-2a. The PD parameters were similar between each dose level of ropeginterferon alfa-2b. The mean Tmax of β2-microglobulin ranged from 118 to 132 h after a single dose of ropeginterferon alfa-2b. The average Emax was 3 mcg/ml in all dose levels and the mean AUEC0–t ranged from 1608 to 1775 h/mcg/ml. The TEAEs were comparable among each treatment group and no death nor drug-related SAE was reported. Ropeginterferon alfa-2b is safe and well tolerated after a single subcutaneous injection up to 270 mcg in healthy Chinese. www.chinadrugtrials.org.cn , CTR20190451.
- Subjects :
- China
business.industry
Injections, Subcutaneous
virus diseases
General Medicine
Pharmacology
Dose level
Antiviral Agents
Healthy Volunteers
Recombinant Proteins
digestive system diseases
Polyethylene Glycols
Subcutaneous injection
Long acting
stomatognathic system
Pharmacokinetics
Pegylated interferon
Pharmacodynamics
PEG ratio
medicine
Humans
Chinese subjects
Pharmacology (medical)
business
medicine.drug
Subjects
Details
- ISSN :
- 18658652 and 0741238X
- Volume :
- 38
- Database :
- OpenAIRE
- Journal :
- Advances in Therapy
- Accession number :
- edsair.doi.dedup.....7c6276b6b71518cf962c2186d281e298