A Phase I Study to Evaluate LIFE-001

Overview

The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.

Participants will attend the site where dosing will be done subcutaneously via direct staff administration and they can only participate in one of the following cohorts: Single Ascending Dose (SAD) Cohorts 1-10: Screening/baseline period of up to 28 days with a 6-day inpatient say and total duration up to 51 days. Single ascending doses of LIFE-001 between 10mg and up to 1500mg or placebo (Day 1) administered under fasting conditions. Increases will be based on safety and tolerability at each dose level. Multiple Ascending Dose (MAD) Cohorts 1-4: Screening/baseline period of up to 28 days with two 6-day inpatient says and total duration up to 91 days. Four doses of LIFE-001 between 50mg and 300mg or placebo on Days 1, 8, 15 and 22 administered under fasting conditions. MAD Cohorts 5-6: Screening/baseline period of up to 28 days with two 5-day inpatient says and total duration up to 73 days. Participants will receive a dose of LIFE-001 or placebo between 50mg and up to 1500mg via SC injection(s) QW on Days 1, 8, 15, and 22 or BIW on Days 1, 4, 8, 11, 15, 18, and 22 (total 7 doses), as determined by the SRC. Exact dose of LIFE-001 for SAD Cohorts 2-10 and MAD will be based on safety, tolerability and pharmacokinetic data from preceding cohorts. After all participants have complete Day 8 (SAD) or Day 29 (MAD), a safety review committee (SRC) will determine if the next dose level cohort will be initiated.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts