Veritus Research Pty Ltd
Bayswater, Victoria, 3163, Australia
Location status: Recruiting
Location contact
Ben Snyder
CONTACT
NCT Number: NCT06904807
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Bayswater, Victoria, 3163, Australia
Location status: Recruiting
Ben Snyder
CONTACT
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 1-10: 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 up to 1500mg 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.
MAD Cohorts 5-6: Screening/baseline period of up to 28 days with two 5-day inpatient says and total duration up to 73 days. Participants will receive a dose of LIFE-001 or placebo between 50mg and up to 1500mg via SC injection(s) QW on Days 1, 8, 15, and 22 or BIW on Days 1, 4, 8, 11, 15, 18, and 22 (total 7 doses), as determined by the SRC.
Exact dose of LIFE-001 for SAD Cohorts 2-10 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously
Single dose of placebo comparator administered subcutaneously
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.
Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.
Time frame: 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
Time frame: 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.
Plasma concentration of LIFE-001
Time frame: 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.
Maximum observed concentration of LIFE-001
Time frame: 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.
Time to maximum observed concentration of LIFE-001
Contact information is provided by the study sponsor or research team.
LifeMine Therapeutics
Industry
A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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