ISSUE NO. 18 — Planning Your First-in-Human Trial
A first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug in that it will be the first opportunity for a drug development sponsor to evaluate the impact of their new chemical entity (NCE) or biologic in humans. Typically, FIH trials with compounds intended for treatment of diseases other than cancers or certain rare non-malignant diseases are conducted using normal healthy volunteers (NHVs), unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.
In Issue 18 of The Altascientist, we provide a stepwise guide for how to plan first-in-human trials to mitigate risk, including:
- submitting an Investigational New Drug (IND) Application
- selecting the starting dose
- designing the trial
- participant safety
- identifying and mitigating potential risks
- recruiting, educating, and retaining study participants
- resources need for study conduct
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Drug addiction is a devastating condition that affects the quality of the user and their families. In this podcast series, we explore the behaviors of individuals who abuse opioids and stimulants, and learn about their patterns of use and motivations to compel them to continue using these drugs through a series of candid interviews with opioid and stimulant recreational drug users.
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Dr.