COVID-19を標的とする新型抗ウイルス剤であるASC10の集団製薬モデリング分析,中国の健康な被験者

Duo Lv^1,2, Sichan Li³, Yi Li⁴

¹Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.

Drug design, development and therapy

|September 2, 2025

まとめ

COVID-19に対する抗ウイルス薬であるASC10-Aは,中国人の成人に予測可能な薬動性を示しています. 体重と食物の摂取により,毎日2回800 mgの投与が推奨されます.

科学分野:

薬理学と薬物の代謝
臨床薬理学
抗ウイルス薬

背景:

ASC10は,COVID-19治療のために研究されている抗ウイルスリボヌクレオシドアナログであるASC10-A (NHC) の口服用二重前薬である.
ASC10は迅速にモルヌピラヴィルに,その後は活性ASC10- A,または直接ASC10- Aに変換されます.

研究の目的:

健康な中国人のASC10- Aの集団薬動性を特徴づける.
COVID-19治療のためのASC10の臨床開発を支援するデータを提供すること.

主な方法:

第I相臨床試験の57人の健康な中国人被験者 (1,634件の観察) のデータを用いて,集団薬物動態モデルを作成した.
定量化限界 (BQL) 以下のデータは,M3方法を使用して処理されました. popPKモデリングにはラプラシアンアルゴリズムが使用されました.
モデルの性能は,適合性グラフ,非パラメトリックブートストラップ,視覚的予測チェックを使用して評価され,シミュレーションでは投与レジメンとコバリアート効果が評価されました.

主要な成果:

1次排泄とトランジットコンパートメント吸収による2つのコンパートメントモデルで,ASC10-Aの薬理学が最もよく記述されています.
体重と食事摂取はASC10- Aの薬理学に影響する重要な共変数として特定された.
シミュレーションにより,ASC10の投与量は1日2回800mgで望ましい被ばくとなり,断食中の被ばくのピーク濃度はより高いことが示された.

結論:

この研究は,健康な中国人のボランティアにおけるASC10- Aの包括的な集団薬動プロファイルを確立した.
この発見は,ASC10の進行中の臨床開発と投与量の最適化を支持する.

キーワード:

ASC10 について ASC10-A コロナウイルスモルヌピラビール人口の薬動学

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