Healthy VolunteersPhase 1NCT06904807
A Phase I Study to Evaluate LIFE-001
A Phase 1 study testing LIFE-001 and LIFE-001 MAD in people with Healthy Volunteers, run by LifeMine Therapeutics at 1 site in Australia.
Trial summary
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LIFE-001 and LIFE-001 MAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Apr 2025to 13 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Veritus Research Pty Ltd
Bayswater, Victoria, 3163
Ben Snyder
About this study
Official title: A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- LIFE-001, Placebo, LIFE-001 MAD, Placebo MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFE-001Drug
Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously
PlaceboDrug
Single dose of placebo comparator administered subcutaneously
LIFE-001 MADDrug
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 MADDrug
Four doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW.
| Study group | Role | What they receive |
|---|---|---|
| LIFE-001 Single Ascending Dose Cohorts | Experimental | LIFE-001 Receives: Drug: LIFE-001 |
| Placebo Single Ascending Dose Cohorts | Placebo comparator | Placebo Receives: Drug: Placebo |
| LIFE-001 Multiple Ascending Dose Cohorts | Experimental | LIFE-001 Receives: Drug: LIFE-001 MAD |
| Placebo Multiple Ascending Dose Cohorts | Placebo comparator | Placebo Receives: Drug: Placebo MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Participant and clinician-reported adverse events
Measured: 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.
Secondary outcomes (3)
Plasma concentration
Plasma concentration of LIFE-001
Measured: 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.
Cmax
Maximum observed concentration of LIFE-001
Measured: 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.
Tmax
Time to maximum observed concentration of LIFE-001
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start7 Apr 2025
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeMine Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Snyder, Principal investigator, Veritus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904807
- Sponsor's protocol ID
- LIFE-001-1001
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
- ClinicalTrials.gov ID
- NCT06904807
- Acronym / sponsor ID
- LIFE-001-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- LifeMine TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LIFE-001 Single Ascending Dose Cohorts | Experimental | Drug: LIFE-001LIFE-001 |
| Placebo Single Ascending Dose Cohorts | Placebo comparator | Drug: PlaceboPlacebo |
| LIFE-001 Multiple Ascending Dose Cohorts | Experimental | Drug: LIFE-001 MADLIFE-001 |
| Placebo Multiple Ascending Dose Cohorts | Placebo comparator | Drug: Placebo MADPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFE-001Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously | Drug | LIFE-001 Single Ascending Dose Cohorts |
| PlaceboSingle dose of placebo comparator administered subcutaneously | Drug | Placebo Single Ascending Dose Cohorts |
| LIFE-001 MADFour 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. | Drug | LIFE-001 Multiple Ascending Dose Cohorts |
| Placebo MADFour doses of placebo administered subcutaneously QW or seven doses of placebo administered subcutaneously BIW. | Drug | Placebo Multiple Ascending Dose Cohorts |
Primary outcome
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.
Participant and clinician-reported adverse events
3 secondary outcomes
Plasma concentration
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.
Cmax
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.
Tmax
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben Snyder principal investigator
Veritus Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIFE-001 and LIFE-001 MAD in people with Healthy Volunteers, run by LifeMine Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Cooper (617-665-5430, clinicaltrials@lifeminetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 4 Nov 2026.