Developing a First-in-Human (FIH) Strategy is a critical step in drug development, ensuring the safe and effective introduction of a new compound to humans. Our consulting services provide the following dose selection approaches:
No Observed Adverse Effect Level (NOAEL): NOAEL is the highest dose of a drug in preclinical studies that doesn’t cause adverse effects. Consultants assist in determining a safe starting dose for human trials by applying a safety margin to the NOAEL. This approach prioritizes safety and minimizes the risk of adverse effects in early-stage trials.
Allometric Scaling: Allometric Scaling involves predicting human dosages based on the body weight of animals and humans while considering metabolic differences. Consultants help in extrapolating preclinical data to estimate a safe and effective starting dose for humans. This method leverages the relationship between body size and metabolism but may need adjustments for specific drug characteristics.
FIH considerations can also be provided on the best population in which to conduct the FIH study in (ie, healthy volunteers versus patients).
- Healthy Volunteers vs. Patients: Our consulting services help biopharma companies decide whether to conduct initial trials in healthy volunteers or patients. Healthy volunteer studies provide insights into a drug’s basic pharmacokinetics and safety profile. Patient studies, on the other hand, offer more disease-specific information but involve additional ethical and safety considerations. Consultants assist in making this strategic choice based on the drug’s mechanism, target population, available preclinical data, and ethical considerations.
Overall, developing a First-in-Human strategy aims to strike a balance between gaining meaningful clinical insights and ensuring patient safety. Identifying the best population to run the FIH study in as well as selecting the initial starting dose by using methods like NOAEL or Allometric Scaling, sets the foundation for subsequent clinical trials and the drug’s successful development journey.
Interested in learning more about Momentum Metrix’s consulting capabilities in putting together a First-in-Human strategy, contact us at information@momentummetrix.com.