First-In-Human Clinical Trials

Transforming Discoveries Into First Steps for Humanity.

Bringing Innovation to Life with Precision and Care.

First-in-human (FIH) clinical trials are a pivotal step in drug and therapy development.

At Conduct Research, we specialize in conducting FIH trials with the utmost care, precision, and adherence to global safety standards. These early-phase trials set the foundation for therapeutic advancements, turning laboratory discoveries into potential life-saving treatments.

First-in-human trials are not just about scientific progress; they are about hope and potential. They mark the initial human step toward bringing groundbreaking therapies to market, providing a foundation for new treatments that could transform lives. At Conduct Research, we treat this responsibility with the utmost seriousness and dedication.

What are First-in-Human Clinical Trials?

FIH trials are early-phase studies that administer investigational drugs to humans for the first time. Typically conducted on small cohorts (20–80 participants), they focus on evaluating safety, pharmacokinetics, and pharmacodynamics while identifying a safe and effective dosing range. These trials often involve healthy volunteers, although for high-risk therapies like oncology drugs, patients with unmet medical needs may participate.

Key Attributes of First-in-Human Clinical Trials

Starting Dose Selection

Choosing the initial dose is pivotal and requires careful consideration to minimize toxicity while ensuring that pharmacological activity can be evaluated in subsequent studies. The Food and Drug Administration (FDA) provides guidelines for starting dose determination, suggesting the conversion of No Observed Adverse Effect Levels (NOAELs) from animal studies into Human Equivalent Doses (HEDs). From there, a safety factor is applied to calculate the Maximum Recommended Starting Dose (MRSD). While this approach determines the upper limit, some studies may begin with doses lower than the MRSD to prioritize safety.

Dose Acceleration

The process of dose escalation is equally critical, involving a structured schedule to test the drug across a range of doses. Sequential dosing—administering the drug to one participant at a time with observation periods between doses—allows for the early detection and management of adverse effects. This strategy also helps gather data to identify the optimal doses for subsequent trial phases.

Study Duration

The duration of an FIH trial depends on the specific characteristics of the investigational drug and its intended effects. Trial timelines are tailored to balance comprehensive data collection with the efficient progression of the study.

Administration Route

The route of administration plays a crucial role in the drug’s effectiveness and the ease of trial execution. For example, oral, intravenous, or subcutaneous administration can influence how the drug interacts with the body, the onset of effects, and the ability to manage adverse reactions. Selecting the optimal route helps enhance the drug’s safety profile and usability.