LIFE-001: Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously
Placebo: Single dose of placebo comparator administered subcutaneously
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.
Placebo MAD: Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.
Study summary
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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 outcome measure(s)
Adverse events — 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. Participant and clinician-reported adverse events
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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