NCT05769920

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 3, 2023

Last Update Submit

April 14, 2023

Conditions

Corneal Epithelial Degeneration

Outcome Measures

Primary Outcomes (1)

  • Dose Limiting Toxicity

    Important Medical Events (ocular) related to study treatment

    28 days

Study Arms (4)

TTHX1114 Dose Level 1

EXPERIMENTAL

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

TTHX1114 Dose Level 2

EXPERIMENTAL

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

TTHX1114 Dose Level 3

EXPERIMENTAL

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

TTHX1114 Dose Level 4

EXPERIMENTAL

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

Interventions

TTHX1114(NM141) Ophthalmic SolutionDRUG

Eye drop twice daily

TTHX1114 Dose Level 1TTHX1114 Dose Level 2TTHX1114 Dose Level 3TTHX1114 Dose Level 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trefoil Clinical Site #132

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Thomas Tremblay

    Trefoil Therapeutics.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

December 6, 2022

Primary Completion

April 12, 2023

Study Completion

April 12, 2023

Last Updated

April 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)