Dose Escalation TTHX1114 Ophthalmic Solution (EPI)

A Phase 1 Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TTHX1114(NM141) Ophthalmic Solution In Healthy Adult Volunteers

Dose escalation 3+3 design with accelerated titration 4 dose levels

Study Overview

• Status: Completed
• Conditions: Corneal Epithelial Degeneration
• Intervention / Treatment: Drug: TTHX1114(NM141) Ophthalmic Solution

Detailed Description

This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels, accelerated titration DL1 and DL2, standard 3+3 design.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Trefoil Clinical Site #132

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female or male, 18 to 65 years of age, Female subjects of child-bearing potential must be non-pregnant
• Able to provide voluntary written informed consent
• Normal ocular function (BCVA 20/20) and anatomy
• Available for and agree to all study procedures including inpatient monitoring, follow-up visits, sample collection, study treatment administration
• Body mass index 18.5 to 35 kg/m^2
• Demonstrated ability to self-administer eye drops

Exclusion Criteria:

• Clinically significant co-morbid ocular conditions
• Co-morbid medical conditions requiring treatment
• Active ocular infection within the 2 weeks prior to Day 1
• Active non-ocular infection requiring antibiotics within the 2 weeks prior to Day 1
• Use of systemic or dermatological cytotoxic chemotherapy within the 1 month prior to Day 1
• Planned contact lens use during the study period
• Use of any investigational product within the 1 month prior to Day 1
• Corticosteroid use in the 1 month prior to Day 1
• Major surgery within the 3 months prior to Day 1
• History of dependence on alcohol or drugs of abuse
• History of intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TTHX1114 Dose Level 1; TTHX1114(NM141) Ophthalmic Solution (DL1): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days	Drug: TTHX1114(NM141) Ophthalmic Solution; Eye drop twice daily
Experimental: TTHX1114 Dose Level 2; TTHX1114(NM141) Ophthalmic Solution (DL2): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days	Drug: TTHX1114(NM141) Ophthalmic Solution; Eye drop twice daily
Experimental: TTHX1114 Dose Level 3; TTHX1114(NM141) Ophthalmic Solution (DL3): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days	Drug: TTHX1114(NM141) Ophthalmic Solution; Eye drop twice daily
Experimental: TTHX1114 Dose Level 4; TTHX1114(NM141) Ophthalmic Solution (DL4): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days	Drug: TTHX1114(NM141) Ophthalmic Solution; Eye drop twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity	Important Medical Events (ocular) related to study treatment	28 days

Collaborators and Investigators

• Sponsor: Trefoil Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: NM141-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No