Dose Escalation TTHX1114 Ophthalmic Solution (EPI)

Trefoil Therapeutics

Status and phase: Completed; Phase 1

Conditions: Corneal Epithelial Degeneration

Treatments: Drug: TTHX1114(NM141) Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05769920

NM141-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

TTHX1114 Dose Level 1

Experimental group

Description:

TTHX1114(NM141) Ophthalmic Solution (DL1): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days

Treatment:

Drug: TTHX1114(NM141) Ophthalmic Solution

TTHX1114 Dose Level 2

Experimental group

Description:

TTHX1114(NM141) Ophthalmic Solution (DL2): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days

Treatment:

Drug: TTHX1114(NM141) Ophthalmic Solution

TTHX1114 Dose Level 3

Experimental group

Description:

TTHX1114(NM141) Ophthalmic Solution (DL3): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days

Treatment:

Drug: TTHX1114(NM141) Ophthalmic Solution

TTHX1114 Dose Level 4

Experimental group

Description:

TTHX1114(NM141) Ophthalmic Solution (DL4): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days

Treatment:

Drug: TTHX1114(NM141) Ophthalmic Solution