Dose Escalation TTHX1114 Ophthalmic Solution

Study Overview
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Brief Summary
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Dose escalation 3+3 design with accelerated titration 4 dose levels

Detailed Description
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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.

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

Conditions
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Corneal Epithelial Degeneration

Intervention / Treatment
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* Drug: TTHX1114(NM141) Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TTHX1114 Dose Level 1<br>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<br>* Eye drop twice daily<br>|
| Experimental: TTHX1114 Dose Level 2<br>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<br>* Eye drop twice daily<br>|
| Experimental: TTHX1114 Dose Level 3<br>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<br>* Eye drop twice daily<br>|
| Experimental: TTHX1114 Dose Level 4<br>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<br>* Eye drop twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

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