Clinical trial NCT06904807: A Phase I Study to Evaluate LIFE-001
Official title: A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: LifeMine Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 1-6: 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: 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

Primary outcomes:
measure: Adverse events
timeFrame: SAD: Predose and Day 1 though Day 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
Secondary outcomes:
measure: Plasma concentration
timeFrame: SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
measure: Cmax
timeFrame: SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
measure: Tmax
timeFrame: SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
Other outcomes:
Locations:
city: Bayswater
country: Australia
facility: Veritus Research Pty Ltd
state: Victoria
Study officials:
affiliation: Veritus Research
name: Stephen Hall
role: PRINCIPAL_INVESTIGATOR
References: