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A Phase I Study to Evaluate LIFE-001

PHASE1RECRUITING

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

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  1. 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
  2. Any abnormal ECG findings, laboratory value or physical examination findings
  3. Positive ethanol, drug screen or cotinine test
  4. Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 7 days
  5. Use of any experimental or investigational device within 30 days
  6. Donation or loss of 500 mL or more of blood within 30 weeks and/or donation of plasma within 30 days

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06904807

Intervention or treatment

DRUG: LIFE-001

DRUG: Placebo

DRUG: LIFE-001

DRUG: Placebo

Conditions

  • Healthy Volunteers

  • Condition: Healthy Volunteers

  • DRUG: LIFE-001 and other drugs

  • Bayswater, Victoria, Australia

  • Sponsor: LifeMine Therapeutics

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Veritus Research Pty Ltd

Select from list below to view details:

  • Veritus Research Pty Ltd

    Bayswater, Victoria, Australia

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Who is running the clinical trial?

LT

LifeMine Therapeutics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: LIFE-001 Single Ascending Dose Cohorts
  • LIFE-001
Drug: LIFE-001
    PLACEBO_COMPARATOR: Placebo Single Ascending Dose Cohorts
    • Placebo
    Drug: Placebo
      EXPERIMENTAL: LIFE-001 Multiple Ascending Dose Cohorts
      • LIFE-001
      Drug: LIFE-001 MAD
        PLACEBO_COMPARATOR: Placebo Multiple Ascending Dose Cohorts
        • Placebo
        Drug: Placebo MAD

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          Adverse eventsParticipant and clinician-reported adverse eventsSAD: Predose and Day 1 though Day 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.

          Secondary Outcome

          MeasureDescriptionTime Frame
          Plasma concentrationPlasma concentration of LIFE-001SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
          CmaxMaximum observed concentration of LIFE-001SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
          TmaxTime to maximum observed concentration of LIFE-001SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
          Are you running this trial?If you're a clinic or sponsor, you can claim this study.
          Claim this trial

          References

          Clinical Trials Gov: A Phase I Study to Evaluate LIFE-001

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