Phase 1 Study of APG-5918 to Assess Safety, Pharmacokinetics, and Early Effectiveness in Healthy Adults and Adults with Anemia

What this Trial Is About

Researchers are evaluating APG-5918, an oral drug, to study its safety, how it moves within the body, and its early effects in healthy adults and patients with anemia. This Phase 1 trial aims to find out if APG-5918 is safe and tolerable and to explore dosing levels that might be effective for anemia treatment. The study includes healthy volunteers and patients with anemia, including those with beta-thalassemia and related conditions. The trial has two parts. Part A randomly assigns healthy volunteers to receive a single dose of APG-5918 or a placebo in a double-blind manner, with dose levels increasing across up to seven groups. Part B involves an open-label, multi-dose approach where anemic patients receive daily APG-5918 for 84 days or until treatment end. The study monitors safety, tolerability, drug levels in the blood, and preliminary effects on hemoglobin. Participants will undergo assessments including blood tests to measure drug concentration and hemoglobin levels, and monitoring for any adverse events up to 7 days in Part A and 84 days or until treatment end in Part B. The trial includes physical exams, lab tests, and ECGs to ensure safety. Total participation duration varies, with regular visits to assess how well the drug is tolerated and its early effects on anemia.

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.