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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: Placebo MAD; Drug: LIFE-001; Drug: LIFE-001 MAD

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Simon Cooper; Phone Number: 617-665-5430; Email: clinicaltrials@lifeminetx.com

Study Locations

• Australia
  • Victoria
    • Bayswater, Victoria, Australia, 3163
      • Recruiting
      • Veritus Research Pty Ltd
      • Contact: Stephen Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIFE-001 Single Ascending Dose Cohorts; LIFE-001	Drug: LIFE-001; Single dose of LIFE-001 between 10mg and 750mg administered subcutaneously
Placebo Comparator: Placebo Single Ascending Dose Cohorts; Placebo	Drug: Placebo; Single dose of placebo comparator administered subcutaneously
Experimental: LIFE-001 Multiple Ascending Dose Cohorts; LIFE-001	Drug: LIFE-001 MAD; Four doses of LIFE-001 between 50mg and 750mg administered subcutaneously seven days apart
Placebo Comparator: Placebo Multiple Ascending Dose Cohorts; Placebo	Drug: Placebo MAD; Four doses of placebo comparator administered subcutaneously seven days apart

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LifeMine Therapeutics
• Investigators: Principal Investigator: Stephen Hall, Veritus Research

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LIFE-001-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No