Healthy Volunteers
Conditions
Brief summary
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
Detailed 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 1-10: 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.
Interventions
DRUGLIFE-001
Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously
DRUGPlacebo
Single dose of placebo comparator administered subcutaneously
DRUGLIFE-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.
DRUGPlacebo MAD
Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.
Sponsors
LifeMine Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration | 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 |
| Cmax | 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 |
| Tmax | 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 |
Countries
Australia
Contacts
CONTACTSimon Cooper
PRINCIPAL_INVESTIGATORBen Snyder
Veritus Research
Outcome results
None listed