Study Evaluating the Safety and Effects of CTX001 on Iron Levels in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating CTX001, an investigational oral treatment, for conditions where the body lacks enough usable iron or has trouble storing or moving iron properly, leading to anemia. These conditions include chronic kidney disease, bone marrow diseases, intestinal diseases, and bleeding disorders. The study aims to understand the safety profile, side effects, how CTX001 is absorbed and processed by the body, and its effects on blood iron levels when taken with or without iron supplements and food. Participants will receive CTX001 or placebo in several groups, including single ascending doses, food effect studies, and multiple ascending doses. CTX001 is given as a pill and may be taken alone or with iron tablets under fasting or after a high-fat meal. The study includes up to five sequential single dose groups and up to three multiple dose groups to assess how the drug behaves under different conditions. During the study, participants will be monitored closely for side effects and changes in physical exams, lab tests, vital signs, and heart function over about 15 days after dosing. Blood samples will be taken at several time points to measure drug levels and iron-related markers such as serum iron, transferrin, transferrin saturation, and ferritin. Participants health and safety will be assessed throughout to understand CTX001s effects and tolerability in healthy adults aged 18 to 55.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.