The objective of this study was to evaluate the pharmacokinetics, pharmacodynamic response, and safety of single intravenous (IV), intramuscular (IM), and subcutaneous (SQ) doses of interferon alfa-n3. Six healthy adults received 10 million units of IV, IM, and SQ interferon alfa-n3 in a randomized three-period crossover fashion. Serum interferon alfa-n3 concentrations and 2'-5'-oligoadenylate synthetase (2-5[A] synthetase) activity in peripheral blood mononuclear cells were determined after each dose. Extravascular administration significantly increased mean serum interferon alfa-n3 AUC values (1152 ± 214, 944 ± 209, and 576 ± 188 U·h/mL, p < 0.001, with SQ, IM, and IV administration, respectively) and 2-5(A) synthetase activity at 36 and 48 hours after dosing. Mild to moderate flu-like symptoms were reported by all 6 subjects, with no route-related difference in type or incidence. Interferon alfa-n3 is generally well tolerated by the IV, IM, and SQ routes, with IM and SQ administration maximizing serum exposure and 2-5(A) synthetase activity. (C) 2000 the American College of Clinical Pharmacology.
|Original language||English (US)|
|Number of pages||10|
|Journal||Journal of Clinical Pharmacology|
|State||Published - Jan 1 2000|
All Science Journal Classification (ASJC) codes
- Pharmacology (medical)