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NCT07385430 · ClinicalTrials.gov registry record · Phase 1
Study of LGW16-03 To Identify Nerves
A Phase 1 study, sponsored by Eric R. Henderson.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT07385430: Recruiting Phase 1 study, sponsored by Eric R. Henderson.
NCT07385430 is a Phase 1 study that is actively recruiting participants, run by Eric R. Henderson. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07385430, a Phase 1 study, is actively recruiting participants, sponsored by Eric R. Henderson.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging contrast, and 2) characterizing the pharmacokinetics of LGW16-03. Participants will receive a one-time intravenous infusion of the investigational drug (LGW16-03) prior to their planned surgery. Participants' vitals will be closely monitored and will have blood samples taken at regular intervals. Fluorescence images of their major nerve will be taken during surgery. Participants will have one study follow-up visit approximately 30 days after their surgery.
Primary Outcome
This study's primary outcome is safety, which will be evaluated by the occurrence of treatment-related adverse events, with attention to frequency and severity as determined by CTCAE v5.0.
Interventions
- DRUG LGW16-03
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2026-06-15 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 1 |
What NCT07385430 shows while recruiting
NCT07385430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which LGW16-03 is the first listed.
NCT07385430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07385430 about?
NCT07385430 is a clinical study titled "Study of LGW16-03 To Identify Nerves". The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging...
What is the current status of trial NCT07385430?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2026-06-15. Estimated completion is 2027-08-01.
What interventions are being tested in trial NCT07385430?
The interventions under investigation include: LGW16-03 (DRUG).
Who is sponsoring clinical trial NCT07385430?
This trial is sponsored by Eric R. Henderson, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07385430's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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