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: LIFE-001; Drug: LIFE-001 MAD; Drug: Placebo 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 1-10: 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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• 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: Ben Snyder

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 up to 1500mg 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 up to 1500mg administered subcutaneously QW or seven doses of LIFE-001 between 50mg and up to 1500mg administered subcutaneously BIW.
Placebo Comparator: Placebo Multiple Ascending Dose Cohorts; Placebo	Drug: Placebo MAD; Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.

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 Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration	Plasma concentration of LIFE-001	SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.
Cmax	Maximum observed concentration of LIFE-001	SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.
Tmax	Time to maximum observed concentration of LIFE-001	SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.

Collaborators and Investigators

• Sponsor: LifeMine Therapeutics
• Investigators: Principal Investigator: Ben Snyder, 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): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 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