About Clinical Research

A clinical research study is a scientific investigation designed to answer important questions about an investigational drug, such as:

Is it safe?

Does it work?

Which dose may work best?

Are there any side effects?

This is a phase 1 study, which means it is evaluating the study drug’s safety in people and its potential effectiveness at lowering oxalate in the body. All study drugs must be tested in clinical research studies before they are approved and available to be prescribed by doctors.

Clinical research studies are also monitored by an independent Institutional Review Board (IRB) or Ethics Committee (EC), composed of physicians and experts who are not participating in the study and who are responsible for protecting the safety and rights of participants.

Choosing to take part in a clinical research study is a big decision.

The study team wants to make sure that you’re comfortable with all aspects of participating in a clinical research study. The team will speak with you and go over a document called an Informed Consent Form, which will help you understand what the study is about, the potential risks and benefits, and what will be involved before you agree to participate. If you are eligible and choose to participate in the study, you will sign the Informed Consent Form.

Once you are a participant, you can decide to stop participating at any time and for any reason.