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Recruiting NCT06904807

A Phase I Study to Evaluate LIFE-001

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIFE-001, Placebo, LIFE-001 MAD, Placebo MAD.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Drug LIFE-001
    Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously
  • Drug Placebo
    Single dose of placebo comparator administered subcutaneously
  • 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.
  • Drug Placebo MAD
    Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Veritus Research Pty Ltd — Bayswater

Identifiers

NCT: NCT06904807 · LIFE-001-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗