Whenever a new drug comes onto the market, it's the end result of years of research and clinical trials that confirm the efficacy of the drug. The research happens in pharmaceutical labs, research universities, and some government research centers. But what about the clinical trials—how do those work?

Clinical research trials go through four distinct phases before the new medications are released to the medical community, but Phase 1 is probably the most critical since this is the one that determines whether the drug is safe. Who participates in clinical trials? Everyday people such as yourself do. As a world leader in clinical research, Celerion is here to cover what Phase 1 of a clinical trial is and why it matters in medical research.

What is a Phase 1 Clinical Trial

A Phase 1 trial is the first testing that involves human beings. The goal of these studies is twofold: what are the potential side effects of the investigational drug, and what is the highest safe dosage of this new therapy? 

With many new drugs, the side effects are unknown until an actual person is taking the medication. 

When a trial begins, a small group of participants (the cohort) are given a very low dose of the new treatment and are watched closely for side effects. 

A second, larger cohort is then given a larger dose, and the process continues until doctors find the balance between drug dosage and tolerable side effects. 

As the cohort grows and participants have greater exposure to the drug, the risks of side effects increase. 

Participant safety is the primary concern of Phase 1 trials. 

Researchers know how certain chemical combinations typically react in people, but they don't know how this exact new cocktail will affect trial participants and actual patients. 

In most Phase 1 clinical trials, participants are healthy, with no signs of the disease being treated. 

Requirements for Phase 1 Trials

There is one fundamental requirement for participating in a Phase 1 clinical trial—you should be in good health. 

The typical participant is between 18 and 55 years old. 

Individual trials may require a more specific demographic—gender, race, ethnic origin, and the like. 

How to Find Out if You're Eligible

If you're interested in volunteering for Phase 1 clinical trials and you live in Lincoln, Nebraska, Phoenix, Arizona, or Belfast in Northern Ireland, you can sign up for trials with Celerion at one of our research facilities. You'll enroll online, and will undergo a subsequent screening process to confirm your eligibility. The Celerion team will review your current health and medical history—it's not so different from a regular physical exam. If you qualify for an upcoming study, the team will give you more information about your responsibilities and commitment as the time for the trial approaches. 

A Phase 1 trial can last a few weeks or several months. Since the research team will monitor you closely, you may be required to stay on the trial site. 

This means you may need to take time from work or classes. 

As part of signing up for a clinical trial with Celerion, you will be compensated for your time after the study has been completed. 

How Phase 1 Trials Help

There's an old saying that a journey of a thousand miles begins with a single step, and Phase 1 trials are that single step. Lab tests can't come close to mimicking the human response, so it's crucial for volunteers to be involved in this initial testing. These tests establish a baseline for further Phase 2, 3 and 4 trials. In Phase 1, researchers get their first real confirmation that a new investigational therapy works and its potential side effects.

Interested in Phase 1 Clinical Trials? Contact Us Today!

At Celerion, we welcome interested individuals to come to tour our facilities and learn about the clinical trial evaluation process and upcoming trials. 

You may go ahead and enroll for a study while you're here. If there's nothing on the horizon that you're qualified for, 

Image Credit: Rawpixel.com, shutterstock