A Phase I Study to Evaluate LIFE-001

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2026-03-31

Brief Summary

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

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Detailed Description

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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 1-7: 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 500mg 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 1-5: 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 500mg or placebo on Days 1, 8, 15 and 22 administered under fasting conditions.

Exact dose of LIFE-001 for SAD Cohorts 2-7 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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LIFE-001 Single Ascending Dose Cohorts

LIFE-001

Group Type EXPERIMENTAL

LIFE-001

Intervention Type DRUG

Single dose of LIFE-001 between 10mg and 500mg administered subcutaneously

Placebo Single Ascending Dose Cohorts

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of placebo comparator administered subcutaneously

LIFE-001 Multiple Ascending Dose Cohorts

LIFE-001

Group Type EXPERIMENTAL

LIFE-001 MAD

Intervention Type DRUG

Four doses of LIFE-001 between 50mg and 500mg administered subcutaneously seven days apart

Placebo Multiple Ascending Dose Cohorts

Placebo

Group Type PLACEBO_COMPARATOR

Placebo MAD

Intervention Type DRUG

Four doses of placebo comparator administered subcutaneously seven days apart

Interventions

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LIFE-001

Single dose of LIFE-001 between 10mg and 500mg administered subcutaneously

Intervention Type DRUG

Placebo

Single dose of placebo comparator administered subcutaneously

Intervention Type DRUG

LIFE-001 MAD

Four doses of LIFE-001 between 50mg and 500mg administered subcutaneously seven days apart

Intervention Type DRUG

Placebo MAD

Four doses of placebo comparator administered subcutaneously seven days apart

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes