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

The main objective of first-in-human (FIH) trials is to determine the starting dose of a new drug, one that is low enough to provide minimal to no safety and toxicity risks and allows the highest dosage/benefit for the intended trial.

The manufacture of the drug product for clinical trials is of critical importance, as the formulation, manufacturing, and assessment of a drug candidate during FIH trials can

 be contributing factors in whether the drug safely provides the correct dosage and, ultimately, gains regulatory approval. Decisions made during early-phase development, when the compound is being used in a clinical research setting, provide significant learnings for its progression through later phase research. Integration is key — ensuring that information gathered at the clinic is efficiently incorporated into the manufacturing process is a major contributor to the goal of achieving marketing approval.