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NCT07385430

Study of LGW16-03 To Identify Nerves

Not yet recruiting Phase 1 Last updated 18 March 2026
What this trial tests

Phase 1 trial testing LGW16-03 in Adults in 38 participants. Not yet recruiting.

Timeline
1 May 2026
Primary endpoint
1 August 2027
1 August 2027

Quick facts

Lead sponsorEric R. Henderson
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment38
Start date1 May 2026
Primary completion1 August 2027
Estimated completion1 August 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eric R. Henderson — full company profile →

Who can join

18 and older, any sex, with Adults or Open-field Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07385430.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing