NCT06904807

A Phase I Study to Evaluate LIFE-001

A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: LifeMine Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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 1-9: 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 750mg 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 1-6: 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 750mg or placebo on Days 1, 8, 15 and 22 administered under fasting conditions. Exact dose of LIFE-001 for SAD Cohorts 2-9 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

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LIFE-001	Single dose of LIFE-001 between 10mg and 750mg administered subcutaneously
DRUG	Placebo	Single dose of placebo comparator administered subcutaneously
DRUG	LIFE-001 MAD	Four doses of LIFE-001 between 50mg and 750mg administered subcutaneously seven days apart
DRUG	Placebo MAD	Four doses of placebo comparator administered subcutaneously seven days apart

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-11-13
• Completion: 2026-11-13
• First posted: 2025-04-01
• Last updated: 2026-03-19

Locations

1 site across 1 country: Australia