First-in-human

CRS is qualified for excellent support

Timely and accurate data regarding the safety and efficacy of an investigational medicinal product (IMP) is crucial for the success at every stage of drug discovery and development. In this regard CRS applies its high level of experience and capabilities to deliver excellent support for First-in-Human (FiH) clinical trials.

CRS has all it takes to successfully conduct first-in-human clinical trials

The safety and well-being of all trial subjects is always of primary importance for CRS. Along with that we are ready and well prepared to support our clients

  • with the CRS power to recruit perfectly suitable subjects for your FiH trial,
  • with our highly experienced in-house physicians and staff to conduct your trial safely, and
  • with the ability to quickly and efficiently meet deadlines.

As appropriate and agreed with the client, CRS starts FiH studies with a single dose trial and follows on with multiple dose trials and food effect studies.

Over the last five years CRS has successfully performed more than 850 clinical trials. About 5 percent of them were First in human trials.

First-in-human: what is it all about?

According to the European Medicines Agency´s (EMA) “Guideline on strategies to identify and mitigate risk for first-in-human and early clinical trials with investigational medicinal products –– The purpose of FiH trials is to evaluate an investigational medicinal product (IMP) in human first time, to study the human pharmacology, tolerability and safety of the IMP and effects seen in non-clinical studies translate into humans.“

Hence, CRS’ objectives strictly support this: to investigate the pharmacokinetic (PK), pharmacodynamic (PD), the safety and tolerability and also to gain early information on all effects of the IMP on humans.

Studying all IMP effects carefully is essential for the early detection and characterization of any risk related to the new drug and for the implementation of appropriate strategies for risk mitigation.

Pharmacology is the study of the interactions between drugs and a living organism. PK refers to the path a drug takes throughout the body.

The first PK clinical trial with a new IMP, administered for the first time to a human subject, is a critical step in drug development and results are vital for success. Hence, a carefully estimated dose and a properly designed trial are crucial to capture all relevant metrics in a FiH study.

PK/PD modeling can help predict dosing requirements in early clinical trials, making the first dose-range finding studies more informative and clinically significant.

To know how a drug will be absorbed and eliminated could help making decisions regarding the galenic formulation and dosing regimes.

Due to its facilities for online PK evaluation, CRS is able to provide PK data for dose escalation meetings one week after the last subject is dosed in a particular dose group.

PD refers to the body’s biological response to drugs.

Predicting the biological response of small dosing changes is important in early clinical trials. The concentration-effect relationship is the milestone of PD. Identifying the variables that affect this relationship is crucial for a successful development program.

Effective drugs have clearly defined therapeutic windows with regards to dosing, best efficacy, and tolerability. PK/PD modeling can help determine dosing thresholds framing the therapeutic window.

Usually the first type of trial performed with a new IMP in humans is a Single Ascending Dose (SAD) study, which investigates the human response to a single dose of the new drug at several dose levels. Thus, after the first low dose of the new drug has been successfully administered to volunteers of the first cohort, the dose will be increased for the next cohort.

The participants in such First in human clinical trials are carefully selected to avoid risks as far as possible. Besides, CRS’ well trained and highly experienced staffs closely supervise the volunteers during the studies.

Frequent examinations, adverse event questioning, and measurements of vital signs – e.g. electrocardiography (ECG), telemetry, oxygen saturation, and safety laboratory – are some of the tools to ensure the safety of volunteers during the First in human studies. Monitoring for at least 24 hours with an in-house investigator and the cooperation with the nearest first aid hospital additionally ensure the subjects’ safety.

CRS PROVIDES FULL SAFETY DATA WITHIN SHORTEST TIME

CRS strictly supports all recommendations, rules, and guidelines of competent authorities related to First in human clinical trials. During such trials we maintain close contact with our clients. And we are able to provide full safety data for the dose escalation within shortest time. Thus we quickly release crucial data for our clients’ further decision-making.

• Single Ascending Dose (SAD) & Multiple Ascending Dose (MAD) trials
• Combined protocols: SAD/MAD + food + Proof of Concept (POC) trials.

CRS embraces the notion that clarity and simplicity lead to good decisions. We take complex PK principles and make them understandable and usable for common sense drug development. Many of our PK consultants have 15 to 30 years of industry experience. They conduct highly sophisticated analyses in a fully validated computing environment with the latest PK modeling software.

REACHING OUT IS EASY AND FAST – LET’S TALK

Prof. Dr. Thomas Forst

Chairman of the Executive Board

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Martin Mulder

Senior Vice President Corporate & Business Development

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BACK TO OVERVIEW

CRO Leadership Awards 2019

CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability.

European Biotechnology Guide

Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019.

EcoVadis – CSR Rating

Based on the CSR rating by EcoVadis in 2022 CRS has been granted Silver Recognition Level.