Corneal Epithelial Degeneration
Conditions
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.
Interventions
DRUGTTHX1114(NM141) Ophthalmic Solution
Eye drop twice daily
Sponsors
Trefoil Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity | 28 days | Important Medical Events (ocular) related to study treatment |
Countries
United States
Outcome results
None listed