Drug Development & Regulation

Phase I Clinical Trial

TRFaz I Klinik Araştırma
Also known as:Phase 1 trial · First-in-human study

The first stage of testing an investigational drug in humans, usually in a small number of healthy volunteers, designed mainly to assess safety, tolerability, pharmacokinetics and, where possible, pharmacodynamics.

In depth

Typical designs are single ascending dose (SAD) and multiple ascending dose (MAD) studies with sentinel dosing and predefined stopping rules. The starting dose is derived from preclinical data such as the NOAEL or, for high-risk agents, the minimal anticipated biological effect level (MABEL). Cytotoxic anticancer drugs are usually tested in patients rather than healthy volunteers.

Other clinical pharmacology studies commonly performed at this stage include food-effect, drug–drug interaction, relative bioavailability and renal or hepatic impairment studies. Results guide dose selection for Phase II and supply much of the pharmacokinetic information later found in the SmPC.

Clinical pearl

Renal and hepatic impairment and interaction studies, often classed as Phase I, underpin the dose-adjustment and interaction advice in SmPC sections 4.2 and 4.5.

TRIn Turkish

Faz I Klinik Araştırma

Araştırma ilacının insanlarda test edildiği ilk aşamadır; genellikle az sayıda sağlıklı gönüllüde yürütülür ve başlıca güvenliliği, tolere edilebilirliği, farmakokinetiği ve mümkünse farmakodinamiği değerlendirmeyi amaçlar.

Tipik tasarımlar, gözcü (sentinel) dozlama ve önceden tanımlanmış durdurma kurallarıyla yürütülen tek artan doz (SAD) ve çoklu artan doz (MAD) çalışmalarıdır. Başlangıç dozu NOAEL gibi klinik öncesi verilerden, yüksek riskli ürünlerde ise beklenen en düşük biyolojik etki düzeyinden (MABEL) türetilir. Sitotoksik antikanser ilaçlar genellikle sağlıklı gönüllüler yerine hastalarda test edilir.

Bu aşamada sıklıkla yürütülen diğer klinik farmakoloji çalışmaları besin etkisi, ilaç–ilaç etkileşimi, göreceli biyoyararlanım ve böbrek ya da karaciğer yetmezliği çalışmalarıdır. Sonuçlar Faz II için doz seçimine yön verir ve daha sonra KÜB'de yer alacak farmakokinetik bilgilerin büyük bölümünü sağlar.

Çoğunlukla Faz I kapsamında değerlendirilen böbrek/karaciğer yetmezliği ve etkileşim çalışmaları, KÜB'ün 4.2 ve 4.5 bölümlerindeki doz ayarlaması ve etkileşim önerilerinin dayanağıdır.

Diğer adları:Faz 1 klinik araştırma · İnsanda ilk kez uygulama çalışması
Updated 24.09.2026 0 views Educational reference — verify against current sources before clinical use.

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 Phase II Clinical TrialFaz II Klinik Araştırma

The stage of clinical development in which an investigational drug is first given to patients with the target condition to obtain preliminary evidence of efficacy, explore the dose–response relationship and further characterize safety.

 PharmacokineticsFarmakokinetik

The branch of pharmacology that describes what the body does to a drug: the time course of its absorption, distribution, metabolism and excretion (ADME) and the resulting concentrations in plasma and tissues.

 No-Observed-Adverse-Effect LevelAdvers Etki Gözlenmeyen Düzey

The highest tested dose or exposure level at which no biologically or statistically significant increase in adverse effects is observed compared with controls in a toxicity study.

 Good Clinical Practiceİyi Klinik Uygulamalar

An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials, ensuring that participants' rights, safety and well-being are protected and that trial data are credible.

 Informed ConsentBilgilendirilmiş Onam

A person's voluntary agreement to take part in research or to undergo treatment, given after receiving and understanding adequate information about its purpose, procedures, risks, benefits and alternatives.