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

NM141-001

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

2022-12-06

2023-04-12

2023-04-12

Completed

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2023-04-18