Key Aspects of First-in-Human Clinical Trials

First-in-human (FIH) clinical trials mark a significant turning point in drug development, where a new therapy moves from the lab to being tested in humans for the very first time. An FIH study is not just a milestone in scientific discovery; it represents an intricate balance between innovation and patient safety.

At Navitas Life Sciences, we are at the forefront of conducting efficient FIH studies, leading with a commitment to precision, collaboration, and safety.

What Are First in Human Clinical Trials?

First in human (FIH) clinical trials represent a significant step in the drug development process. These trials mark the initial administration of a new investigational drug to humans, following extensive testing using preclinical models.

FIH trials are usually conducted with healthy volunteers, but in certain high-risk cases, such as antitumor drugs, they may include patients who have limited options for existing treatments.

Challenges in First in Human Trials

Conducting first in human trials is inherently complex due to the fact that it is the first time an investigational drug is introduced into humans. One of the most critical challenges is ensuring participant safety, which is paramount throughout the entire trial process. The increasingly intricate designs of modern clinical trials add to the complexity of FIH trials, requiring thorough planning and flexible protocols.

A first in human study often involves a small cohort of participants, limiting the ability to observe less frequent side effects. Various factors, such as the appropriateness of preclinical models, the presence or absence of biomarkers, and the demographic characteristics of the participants, can influence the outcome of these studies. Despite these complexities, the ultimate goal of FIH trials is to ensure that the investigational drug is safe and effective before advancing to larger studies. Prioritizing safety at every stage in first in human studies is essential for the trial’s success.

Overcoming Challenges in FIH Study

The success and safety of these trials rely heavily on the expertise of a multidisciplinary team. Their combined skills ensure that these trials adhere to the highest standards of safety and ethical conduct while evaluating the pharmacokinetics, pharmacodynamics, and safety of the drug in humans for the first time.

A Safety-First Approach to First-in-Human Clinical Trials

First-in-human clinical trials are unique. They demand more than technical expertise—they require a deep understanding of the therapeutic landscape, careful protocol design, and an unwavering commitment to the safety of participants.

At Navitas Life Sciences, we recognize the gravity of these trials and employ a multi-pronged approach to guarantee that patient safety is never compromised.

• Risk Management : From the outset, our comprehensive risk assessment strategies are in place. By continuously monitoring safety data, we make proactive adjustments to safeguard participants.
• Protocol Design : Our team of experts works collaboratively, integrating scientific knowledge and patient-centric focus to create protocols that optimize therapeutic efficacy while ensuring safety.
• Safety Oversight : Safety remains paramount throughout the trial. Data Safety Monitoring Boards (DSMBs) and frequent safety reviews are crucial in quickly identifying and addressing any potential risks.
• Dose Selection and Acceleration : Our strategic dose selection and adaptive designs ensure that we reach the most effective dose levels safely and quickly, further enhancing the efficiency of our trials.

Ongoing and Past First in Human Trials

There are two ongoing FIH trials, each uniquely positioned to explore breakthrough treatments in oncology that could redefine patient care. We have successfully delivered numerous FIH trials in the past, demonstrating our extensive experience and expertise in this critical area. These studies not only showcase our capabilities but also highlight our steadfast commitment to advancing medical science while safeguarding patient interests.

End-to-End Clinical Trial Services

At Navitas, we offer comprehensive, end-to-end clinical trial services that support sponsors from initial concept through to study completion. Our services include protocol development, regulatory submissions, clinical monitoring, site management, data analysis, and final reporting, ensuring seamless execution at every step.

Cross-Functional Collaboration

The success of any clinical trial lies in its execution, and our dedicated Clinical Project Managers (CPMs) are the linchpin of our operations. With extensive experience and a collaborative mindset, our CPMs work closely with cross-functional teams—including regulatory, data management, and clinical operations—to keep projects aligned with objectives and timelines. Our CPMs are trained to ensure that every aspect of the trial is meticulously managed, risks are proactively identified, and solutions are swiftly implemented.

Navitas Life Sciences is committed to leading the way in FIH trials through innovative strategies, rigorous safety protocols, and collaborative efforts. Our approach ensures that we not only advance medical science but also prioritize patient safety and well-being at every step. We believe our expertise will help your drug reach the next level of advancement.

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