NCT06904807|RecruitingPhase 1
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
Loading search results
A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
Sponsor study identifier
interventional
160
1 country
1
Study Start
April 7, 2025
Actual (reported)Primary Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2025
Actual (reported)April 1, 2025
Actual (reported)April 7, 2025
Actual (reported)November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Adverse events
Participant and clinician-reported 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.
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.
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.
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.
LIFE-001
Placebo
LIFE-001
Single dose of LIFE-001 between 10mg and up to 1500mg administered subcutaneously
Single dose of placebo comparator administered subcutaneously
Veritus Research Pty Ltd
Bayswater, Victoria, 3163, Australia
Ben Snyder
Veritus Research
First Submitted
March 14, 2025
First Posted
April 1, 2025
Study Start
April 7, 2025
Actual (reported)Primary Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers
Placebo
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 7, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: