Phase I Study to Assess Safety and Tolerability of LIFE-001 in Healthy Adults Aged 18 to 65

What this Trial Is About

This research aims to evaluate the safety and tolerability of LIFE-001 in healthy adult volunteers aged 18 to 65 years. The study is a Phase I trial focusing on single ascending doses SAD and multiple ascending doses MAD to understand how the drug behaves in the body and its effects. It is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational drug LIFE-001 compared to placebo. Participants will be assigned to one of several cohorts receiving either single or multiple subcutaneous doses of LIFE-001 or placebo. The SAD cohorts involve dosing between 10mg and 1500mg with a 6-day inpatient stay and a total duration of up to 51 days. MAD cohorts receive multiple doses ranging from 50mg to 1500mg on various schedules, including weekly or twice weekly injections, with inpatient stays of 5 to 6 days and total participation lasting up to 91 days. Dose escalations depend on safety and tolerability reviews by a safety committee. During the study, participants will attend scheduled visits for dosing and monitoring under fasting conditions. Assessments include tracking adverse events, plasma drug concentrations, and pharmacokinetic measures such as maximum concentration and time to maximum concentration at specified intervals post-dosing. Safety monitoring includes physical examinations, ECGs, laboratory testing, and drug and alcohol screening. The total participation duration varies by cohort but includes screening, inpatient stays, and follow-up visits extending up to 91 days.

A Phase I Study to Evaluate LIFE-001