A Phase I Study to Evaluate LIFE-001
A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
LifeMine Therapeutics
150 participants
Apr 7, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
Single dose of LIFE-001 between 10mg and 750mg administered subcutaneously
Single dose of placebo comparator administered subcutaneously
Four doses of LIFE-001 between 50mg and 750mg administered subcutaneously seven days apart
Four doses of placebo comparator administered subcutaneously seven days apart
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06904807