A Phase I Study to Evaluate LIFE-001

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: LIFE-001; Drug: Placebo

• Registration Number: NCT06904807
• Lead Sponsor: LifeMine Therapeutics

Brief 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 1-6: 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 300mg 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.

Exact dose of LIFE-001 for SAD Cohorts 2-6 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.

Study Timeline

• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-01
• Study Start: 2025-04-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Female or male between the ages of 18 and 65 years, inclusive
• Medically healthy (without significant medical issues, e.g. high blood pressure)
• Must provide written informed consent

Exclusion Criteria

• Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant's safety or interfere with the absorption, distribution or excretion of the study drug
• Any abnormal ECG findings, laboratory value or physical examination findings
• Positive ethanol, drug screen or cotinine test
• Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 7 days
• Use of any experimental or investigational device within 30 days
• Donation or loss of 500 mL or more of blood within 30 weeks and/or donation of plasma within 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIFE-001 Single Ascending Dose Cohorts	LIFE-001	LIFE-001
Placebo Single Ascending Dose Cohorts	Placebo	Placebo
LIFE-001 Multiple Ascending Dose Cohorts	LIFE-001	LIFE-001
Placebo Multiple Ascending Dose Cohorts	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Adverse events	SAD: Predose and Day 1 though Day 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.	Participant and clinician-reported adverse events

Secondary Outcome Measures

Name	Time	Method
Plasma concentration	SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.	Plasma concentration of LIFE-001
Cmax	SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.	Maximum observed concentration of LIFE-001
Tmax	SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.	Time to maximum observed concentration of LIFE-001

Trial Locations

Locations (1)

Veritus Research Pty Ltd; 🇦🇺 Bayswater, Victoria, Australia