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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06904807




Registration number
NCT06904807
Ethics application status
Date submitted
14/03/2025
Date registered
1/04/2025
Date last updated
13/05/2025

Titles & IDs
Public title
A Phase I Study to Evaluate LIFE-001
Scientific title
A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
Secondary ID [1] 0 0
LIFE-001-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LIFE-001
Treatment: Drugs - Placebo
Treatment: Drugs - LIFE-001
Treatment: Drugs - Placebo

Experimental: LIFE-001 Single Ascending Dose Cohorts - LIFE-001

Placebo comparator: Placebo Single Ascending Dose Cohorts - Placebo

Experimental: LIFE-001 Multiple Ascending Dose Cohorts - LIFE-001

Placebo comparator: Placebo Multiple Ascending Dose Cohorts - Placebo


Treatment: Drugs: LIFE-001
Single dose of LIFE-001 between 10mg and 300mg administered subcutaneously

Treatment: Drugs: Placebo
Single dose of placebo comparator administered subcutaneously

Treatment: Drugs: LIFE-001
Four doses of LIFE-001 between 50mg and 300mg administered subcutaneously seven days apart

Treatment: Drugs: Placebo
Four doses of placebo comparator administered subcutaneously seven days apart
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
SAD: Predose and Day 1 though Day 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
Secondary outcome [1] 0 0
Plasma concentration
Timepoint [1] 0 0
SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
Secondary outcome [2] 0 0
Cmax
Timepoint [2] 0 0
SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
Secondary outcome [3] 0 0
Tmax
Timepoint [3] 0 0
SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Veritus Research Pty Ltd - Bayswater
Recruitment postcode(s) [1] 0 0
3163 - Bayswater

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LifeMine Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Hall
Address 0 0
Veritus Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Simon Cooper
Address 0 0
Country 0 0
Phone 0 0
617-665-5430
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06904807