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Recruiting

NCT Number: NCT06904807

A Phase I Study to Evaluate LIFE-001

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

Recruiting

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Veritus Research Pty Ltd

Bayswater, Victoria, 3163, Australia

Location status: Recruiting

Location contact

Ben Snyder

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIFE-001

Drug

Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously

Placebo

Drug

Single dose of placebo comparator administered subcutaneously

LIFE-001 MAD

Drug

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 MAD

Drug

Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.

Primary outcomes

  1. Adverse events

    Time frame: 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.

    Participant and clinician-reported adverse events

Secondary outcomes

  1. Plasma concentration

    Time frame: 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.

    Plasma concentration of LIFE-001

  2. Cmax

    Time frame: 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.

    Maximum observed concentration of LIFE-001

  3. Tmax

    Time frame: 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.

    Time to maximum observed concentration of LIFE-001

Study contacts

Contact information is provided by the study sponsor or research team.

Simon Cooper

CONTACT

[email protected]

617-665-5430

Sponsors and collaborators

Lead sponsor

LifeMine Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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