A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects

Healthy

Rationale for the Study: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China. Study Design: This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.

Rationale for the Study: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China. Study Design: This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex. Four Avonex IM injections will be administered in this study. Due to the long-term use of Avonex by MS patients, a multiple-dose PK/PD study is necessary in order to provide adequate information to evaluate changes in drug concentrations over time in Chinese healthy subjects. Serum levels of interferon beta in Caucasian healthy volunteers have been shown to peak between 3 and 15 hours after administration of Avonex IM at the dose being used in this study and have been shown to decline at a rate consistent with a 10-hour elimination half-life; therefore, accumulation of interferon beta following multiple weekly Avonex IM injections is not anticipated. Exposure of healthy subjects to multiple doses of Avonex in this study is not anticipated to present safety or tolerability issues based on experience from previous Avonex studies that have been conducted in healthy volunteer subjects and MS patients. Flu-like symptoms associated with this dose of Avonex have generally been mostly of mild-to-moderate intensity and of short duration, typically experienced within the first 24 hours after injection. Prophylactic analgesic medication must be administered prior to each Avonex injection during the study which is a recommended practice with the use of interferon therapies in order to ameliorate flu-like symptoms. Study Location: China, at 1 Phase 1 study site. Duration of Treatment and Follow-up: Approximately 2 months, including a 28-day Screening and Baseline period, a 3-week Treatment and blood sampling period and a 14-day Follow-Up period. Statistical Methods: PK/PD parameters will be calculated using non-compartmental methods. Summary statistics for each PK/PD parameter will be calculated. Mean concentration values will be plotted over time both on a linear and a logarithmic scale. The incidence of treatment-emergent AEs will be summarized. Vital signs will be examined to determine the incidence of clinically relevant abnormalities. Laboratory evaluations will be assessed to determine the incidence of abnormalities. Changes in laboratory evaluations will be summarized using shift tables and summary statistics.

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