A Phase I Study to Evaluate LIFE-001

LifeMine Therapeutics

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LIFE-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06904807

LIFE-001-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

LIFE-001 Single Ascending Dose Cohorts

Experimental group

Description:

LIFE-001

Treatment:

Drug: LIFE-001

Drug: LIFE-001

Placebo Single Ascending Dose Cohorts

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

LIFE-001 Multiple Ascending Dose Cohorts

Experimental group

Description:

LIFE-001

Treatment:

Drug: LIFE-001

Drug: LIFE-001

Placebo Multiple Ascending Dose Cohorts

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo