Access to clinical trial data is important for the advancement of medical science. Direct Biologics is committed to conducting clinical research in accordance with applicable laws, regulations, and data privacy requirements.
A clinical trial is a research study conducted to evaluate an investigational product. These studies are designed to assess safety, how the product behaves in the body, and its potential effects in a specific condition. “Investigational” means the product has not been approved by regulatory authorities—such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA)—for a particular use or patient population.
Clinical trials are a critical component of medical research and are required to evaluate investigational products. Before an investigational product can be approved for general use, it must be studied in a series of clinical trials. These studies are designed to evaluate safety and effectiveness in the intended patient population. Many currently available therapies were developed through clinical research focused on conditions with unmet medical needs.
Clinical trials for investigational products are conducted in stages, commonly referred to as “phases.” Each phase is designed with a specific objective and helps researchers gather information about the product’s safety, dosing, and potential effects.
Before clinical trials begin, investigational products are evaluated in a laboratory and non-clinical studies to assess initial safety and biological activity.
Evaluates safety, tolerability, and how the investigational product behaves in the body, typically in a small number of participants.
Further evaluates safety and explores dosing and potential effects in individuals with the condition under study.
Evaluates safety and effectiveness in a larger population to support regulatory review.
Conducted after regulatory approval to evaluate long-term safety and effectiveness in broader patient populations.
Below are the clinical trials currently being conducted by Direct Biologics. Explore each study to learn more about its purpose, eligibility criteria, and participation details.
Phase III
View Study Details
Phase II
View Study Details
All candidate therapies listed on this website are investigational and have not been approved by the U.S. Food and Drug Administration.