Phase 1 Study to Evaluate Safety and Effects of TL-003 Given by IV in Healthy Adults and People With Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics how the drug moves through the body, pharmacodynamics how the drug affects the body, and immune response of TL-003, an investigational drug given intravenously, in healthy adults. This Phase 1 randomized, double-blind, placebo-controlled study includes single ascending dose SAD and multiple ascending dose MAD groups to assess TL-003 in healthy adult participants, as well as open-label assessments in participants with ulcerative colitis. The study involves six groups of 8 participants each, randomized in a 31 ratio to receive either TL-003 or a placebo intravenously. Four groups receive single ascending doses of TL-003 or placebo at increasing dose levels, while two groups receive multiple ascending doses or placebo. The intervention is administered under double-blind conditions to evaluate dose-related safety and drug behavior in the body across different dosing schedules. Participants will undergo safety and laboratory assessments including vital signs, electrocardiograms, and clinical laboratory tests before and after dosing, with follow-up lasting up to 169 days. Researchers will monitor for treatment-emergent adverse events and measure detailed pharmacokinetic parameters such as maximum concentration, time to maximum concentration, half-life, and drug clearance. The study includes careful monitoring of immune response and tolerability throughout its duration, with a total participation period extending several months to capture both immediate and longer-term data.

A Safety and Pharmacokinetics Study of TL-003 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis