Dose Escalation TTHX1114 Ophthalmic Solution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2023-04-12

Brief Summary

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

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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.

Conditions

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Corneal Epithelial Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

TTHX1114(NM141) Ophthalmic Solution

Intervention Type DRUG

Eye drop twice daily

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

Group Type EXPERIMENTAL

TTHX1114(NM141) Ophthalmic Solution

Intervention Type DRUG

Eye drop twice daily

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

Group Type EXPERIMENTAL

TTHX1114(NM141) Ophthalmic Solution

Intervention Type DRUG

Eye drop twice daily

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

Group Type EXPERIMENTAL

TTHX1114(NM141) Ophthalmic Solution

Intervention Type DRUG

Eye drop twice daily

Interventions

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TTHX1114(NM141) Ophthalmic Solution

Eye drop twice daily

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes