A Safety and Efficacy Trial of TTHX1114 in People With CED

NCT ID: NCT04812067

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-10-31

Brief Summary

Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114

Conditions

Corneal Endothelial Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TTHX1114 weekly x 5

TTHX1114 via IC injection weekly x 5

Group Type: EXPERIMENTAL

TTHX1114

Intervention Type: DRUG

engineered FGF-1

Interventions

TTHX1114

engineered FGF-1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, 18 years of age or older
• Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
• Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
• Fellow Eye with 20/100 BCVA or better
• No concurrent ocular or medical condition that would impair the assessment of safety and efficacy

Exclusion Criteria

• Prior exposure to TTHX1114
• Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
• Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
• History of:

• Ocular cancer (including melanoma)
• Herpetic keratitis
• Documented and repeated elevated IOP in either eye
• Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
• Uveitis
• Use of any concomitant medications that may interfere with the assessment of safety and efficacy
• Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trefoil Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Tremblay

Role: STUDY_DIRECTOR

Trefoil Therapeutics.com

Locations

Trefoil Study Site

Atlanta, Georgia, United States

Trefoil Study Site

Washington, Missouri, United States

Countries

United States

Other Identifiers

TTHX-901

Identifier Type: -

Identifier Source: org_study_id