Phase 1 Study Evaluating Safety, Tolerability, and Effects of GL-0719 in Healthy Adults and Patients with Cold Agglutinin Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics how the drug moves through the body, and pharmacodynamics the drugs effects on the body of GL-0719. This first-in-human study includes healthy adult men and women as well as subjects with cold agglutinin disease CAD, a rare condition affecting red blood cells. The study aims to better understand the drugs behavior and potential effects in these groups. The study involves several groups receiving single doses of GL-0719 or placebo through intravenous IV infusion or subcutaneous SC injection. Healthy volunteers are randomized in a 31 ratio to receive either the drug or placebo across different dose levels in sequential cohorts. Separate patient cohorts with CAD receive GL-0719 without placebo. Dosing includes single ascending IV doses in multiple cohorts and SC injections in others. Participants will undergo safety and laboratory evaluations including blood tests, vital signs, physical exams, and monitoring of adverse events from screening through 31 days after dosing. Researchers will measure drug concentrations over time, immune responses, and pilot efficacy biomarkers related to CAD. The study includes follow-up visits to assess safety, drug levels, and immune reactions, with a total participation period of about one month after dosing.

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease