Dose Escalation TTHX1114 Ophthalmic Solution

Phase 1

Completed

• Conditions: Corneal Epithelial Degeneration
• Interventions: Drug: TTHX1114(NM141) Ophthalmic Solution

• Registration Number: NCT05769920
• Lead Sponsor: Trefoil Therapeutics, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2022-12-06
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	28 days	Important Medical Events (ocular) related to study treatment

Trial Locations

Locations (1)

Trefoil Clinical Site #132; 🇺🇸 Cypress, California, United States