A Phase I Study to Evaluate LIFE-001

NCT06904807 | Recruiting Phase 1

• 1 other identifier: LIFE-001-1001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Plasma concentration

  SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.

• Cmax

  SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.

• Tmax

  SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.

Study Arms (4)

LIFE-001 Single Ascending Dose Cohorts

EXPERIMENTAL

LIFE-001

Drug: LIFE-001

Placebo Single Ascending Dose Cohorts

PLACEBO COMPARATOR

Placebo

Drug: Placebo

LIFE-001 Multiple Ascending Dose Cohorts

EXPERIMENTAL

LIFE-001

Drug: LIFE-001 MAD

Placebo Multiple Ascending Dose Cohorts

PLACEBO COMPARATOR

Placebo

Drug: Placebo MAD

Interventions

LIFE-001 DRUG

Single dose of LIFE-001 between 10mg and 750mg administered subcutaneously

LIFE-001 Single Ascending Dose Cohorts

Placebo DRUG

Single dose of placebo comparator administered subcutaneously

Placebo Single Ascending Dose Cohorts

LIFE-001 MAD DRUG

Four doses of LIFE-001 between 50mg and 750mg administered subcutaneously seven days apart

LIFE-001 Multiple Ascending Dose Cohorts

Placebo MAD DRUG

Four doses of placebo comparator administered subcutaneously seven days apart

Placebo Multiple Ascending Dose Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeMine Therapeutics: lead

Study Sites (1)

Veritus Research Pty Ltd

Bayswater, Victoria, 3163, Australia

RECRUITING

Study Officials

• Stephen Hall

  Veritus Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Cooper

CONTACT

617-665-5430; clinicaltrials@lifeminetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 1, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)