Phase 0

Phase 0 studies, also referred to as exploratory IND studies, aim to provide initial insights into a novel drug or treatment’s pharmacokinetics, pharmacodynamics, and mechanism of action in humans.

In a phase 0 study, a small group of healthy volunteers or patients with the targeted disease receive a very low dose of the drug. The primary objective is to gather preliminary data on the drug’s pharmacological properties and potential efficacy. Phase 0 studies are not mandatory, but they can offer valuable insights into a drug’s potential before committing significant resources to later stages of clinical development.

These studies are typically conducted in a tightly controlled clinical environment with careful monitoring of the participants’ safety and tolerability. Although they do not provide definitive proof of efficacy, phase 0 studies can identify potential issues early on and help optimize drug development strategies.

Our company has extensive experience in designing and conducting phase 0 studies, and we are committed to advancing pharmaceutical research and development. If you have any inquiries regarding our services or how we can help you with your drug development program, please do not hesitate to contact us.