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NCT03545438 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003
A Phase 1 study, sponsored by LIB Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT03545438: Completed Phase 1 study, sponsored by LIB Therapeutics.
NCT03545438 is a Phase 1 study that has completed, run by LIB Therapeutics. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03545438, a Phase 1 study, has completed, sponsored by LIB Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.
Primary Outcome
safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
Interventions
- BIOLOGICAL LIB003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-10-30 |
| Est. Completion | 2018-06-30 |
| Phase | Phase 1 |
What the finished NCT03545438 record still lists
NCT03545438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which LIB003 is the first listed.
NCT03545438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03545438 about?
NCT03545438 is a clinical study titled "Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003". Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.
What is the current status of trial NCT03545438?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2017-10-30. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT03545438?
The interventions under investigation include: LIB003 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03545438?
This trial is sponsored by LIB Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03545438's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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