CRS

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Pioneering
First-in-Human Trials
with Excellence

Leading the Way in Rapid Safety Assessment and
Strategic Trial Design
Your Trusted Partner
for First-in-Human
(FiH) Trial
Timely and accurate assessment of the safety and efficacy of Investigational Medicinal Products (IMPs) is critical at every stage of drug development. At CRS, we leverage our extensive experience and capabilities to ensure exceptional support for First-in-Human (FiH) clinical trials.
The safety and well-being of all our trial subjects is paramount. We are dedicated to:
  • Expert Subject Recruitment: We leverage our extensive networks to recruit highly qualified subjects for your FiH trial.
  • Experienced In-House Team: Our highly skilled in-house physicians and staff ensure the safe and effective conduct of your trial.
  • Efficient Project Management: We meet deadlines swiftly and efficiently to keep your trial on track.
We initiate First-in-Human (FiH) studies with single-dose trials and progress to multiple-dose and food effect studies based on client agreements. Over the past five years, we have successfully conducted over 850 clinical trials, with around 40 dedicated to FiH trials.

Understanding FiH Trials: Pharmacokinetics and Pharmacodynamics

According to the European Medicines Agency (EMA), FiH trials are pivotal in studying the pharmacology, tolerability, and safety of IMPs in humans. We strictly adhere to these objectives, aiming to uncover early insights into the effects of IMPs on human subjects. Comprehensive understanding of the IMP’s pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability profiles is crucial for identifying and mitigating risks early in drug development.

PK/PD modeling aids in predicting dosing requirements, enhancing the informative value of initial dose-ranging studies and informing galenic formulation decisions.

PK: PharmacoKinetics

Pharmacokinetics refers to how drugs are absorbed, distributed, metabolized, and excreted in the body. The initial PK clinical trial for a new investigational medicinal product (IMP) in humans is crucial for drug development. Accurate dosing and well-designed trials are essential to capture all relevant metrics in First-in-Human (FiH) studies.

Our capability for online PK evaluation allows for rapid data generation, providing PK insights for dose escalation meetings within one week of the last subject’s dosing in a specific cohort.

PD: Pharmacodynamics

Pharmacodynamics (PD) describes how drugs affect the body. Predicting biological responses to small dose changes is crucial in early clinical trials. Understanding the concentration-effect relationship is key to successful drug development, helping to establish dosing thresholds that optimize efficacy and tolerability within the therapeutic window.

Dose-Range Finding and Safety

First-in-Human trials typically commence with a Single Ascending Dose (SAD) study, progressively escalating doses to assess human response across multiple levels. Participants are carefully screened to minimize risks, closely monitored by our highly trained staff. Rigorous safety measures, including frequent examinations, adverse event monitoring, and vital signs assessments (e.g., ECG, telemetry, oxygen saturation, safety lab tests), ensure participant safety. Monitoring continues for at least 24 hours post-dosing, overseen by an in-house investigator and in collaboration with nearby medical facilities for immediate response.

Our Comprehensive
First-in-Human (FiH)
Trial Services

At CRS, we prioritize rapid and thorough safety assessment in First-in-Human (FiH) clinical trials, adhering strictly to recommendations and guidelines from regulatory authorities. Throughout these trials, we maintain close communication with our clients to ensure transparency and timely delivery of critical safety data for dose escalation decisions.

We specialize in:

  • Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trials: Sequential dose escalation studies to evaluate safety and
tolerability profiles.
  • Combined Protocols: Integrating SAD, MAD, food effect, and Proof of Concept (POC) trials to streamline data collection and accelerate development timelines.

At CRS, we prioritize rapid and thorough safety assessment in First-in-Human (FiH) clinical trials, adhering strictly to recommendations and guidelines from regulatory authorities. Throughout these trials, we maintain close communication with our clients to ensure transparency and timely delivery of critical safety data for dose escalation decisions.

Contact us today to learn how our expert team and comprehensive services can help you optimize your First-in-Human (FiH) trial.

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