EPI: Dose Escalation TTHX1114 Ophthalmic Solution

Sponsor

Trefoil Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05769920

Collaborator

(none)

Enrollment

Location

Arms

7.3

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Epithelial Degeneration	Drug: TTHX1114(NM141) Ophthalmic Solution	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 6, 2022

Anticipated Primary Completion Date :

Apr 12, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: TTHX1114(NM141) Ophthalmic Solution Eye drop twice daily
Experimental: 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	Drug: TTHX1114(NM141) Ophthalmic Solution Eye drop twice daily
Experimental: 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	Drug: TTHX1114(NM141) Ophthalmic Solution Eye drop twice daily
Experimental: 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	Drug: TTHX1114(NM141) Ophthalmic Solution Eye drop twice daily

Outcome Measures

Primary Outcome Measures

Dose Limiting Toxicity [28 days]
Important Medical Events (ocular) related to study treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trefoil Clinical Site #132	Cypress	California	United States	90630

Sponsors and Collaborators

Trefoil Therapeutics, Inc.

Investigators

Study Director: Thomas Tremblay, Trefoil Therapeutics.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Trefoil Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT05769920

Other Study ID Numbers:

NM141-001

First Posted:

Mar 15, 2023

Last Update Posted:

Mar 15, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ophthalmic Solutions

Study Results

No Results Posted as of Mar 15, 2023