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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug Discovery: Overview01:26

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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The pharmacokinetic phase...
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In Vitro Drug Release Testing: Overview, Development and Validation01:10

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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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薬物開発

Nadir Ulu1, Daniël Henri Swart2,3, Zafer Sezer4,5

  • 1Gen İlaç ve Sağlık Ürünleri A.Ş., Ankara, Turkey.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
まとめ
この要約は機械生成です。

ミトコンドリア機能不全を標的とする新規分子であるSUL-238は、ヒトでの最初の試験において安全性と良好な薬物動態を示しました。この薬剤は、アルツハイマー病やパーキンソン病などの神経変性疾患の治療の可能性を示しています。

キーワード:
SUL-238第1相試験安全性忍容性脳脊髄液移行性神経変性疾患ミトコンドリア機能不全アルツハイマー病パーキンソン病

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科学分野:

  • 神経科学および薬理学;ミトコンドリア生物学;薬物開発

背景:

  • ミトコンドリア機能不全は、アルツハイマー病（AD）およびパーキンソン病（PD）の病態生理に関与しています。;新規低分子であるSUL-238は、前臨床モデルにおいてミトコンドリア機能を高めます。;SUL-238は、ADマウスモデルにおいて、タンパク質発現の改善、アミロイドプラークの減少、および記憶力の向上を示し、可能性を示しています。

研究 の 目的:

  • 健康な成人におけるSUL-238の単回経口投与の安全性、忍容性、および薬物動態を評価すること。;SUL-238の脳脊髄液（CSF）移行性を評価すること。

主な方法:

  • 健康なボランティアを対象とした第1相、無作為化、二重盲検、プラセボ対照、単回経口漸増投与（SAD）試験。;用量は6つのコホートにわたって50 mgから2000 mgの範囲でした。;食事の影響およびCSF/血漿濃度を含む薬物動態（PK）分析が実施されました。

主要な成果:

  • SUL-238は、試験されたすべての用量（50〜2000 mg）で安全かつ忍容性が高く、用量制限性の有害事象はありませんでした。;有害事象は軽度から中等度であり、SUL-238群とプラセボ群で同等でした。;良好な薬物動態プロファイルが観察され、高いCSF移行性を示しました（投与後2時間で平均21.1％、8時間で74.2％）。

結論:

  • SUL-238の単回経口投与（50〜2000 mg）は、健康なボランティアにおいて安全かつ忍容性が高いです。;SUL-238は良好な薬物動態プロファイルを示します。;この薬剤は脳脊髄液への有意な移行を示し、神経学的応用への可能性を支持します。