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A Phase 1/ Phase 2 Study of TTHX1114(NM141)

NCT04520321 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-10-30

Study results available
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Summary

Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study

Conditions

  • Corneal Endothelial Dystrophy
  • Fuchs Endothelial Corneal Dystrophy
  • Pseudophakic Bullous Keratopathy
  • Endothelial Dysfunction

Interventions

DRUG

TTHX1114(NM141)

engineered FGF-1 delivered intracamerally

OTHER

Vehicle (placebo)

Placebo

Sponsors & Collaborators

  • Trefoil Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas M Tremblay, RN BSN · Trefoil Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2021-04-23
Completion
2021-05-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04520321 on ClinicalTrials.gov