Corneal Epithelial DegenerationPhase 1EPINCT05769920
Dose Escalation TTHX1114 Ophthalmic Solution
A Phase 1 study testing TTHX1114(NM141) Ophthalmic Solution in people with Corneal Epithelial Degeneration, run by Trefoil Therapeutics, Inc. at 1 site in United States.
Trial summary
Dose escalation 3+3 design with accelerated titration 4 dose levels Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelial Degeneration
- What is being tested?
- TTHX1114(NM141) Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 12 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Trefoil Clinical Site #132
Cypress, California, 90630
About this study
Official title: A Phase 1 Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TTHX1114(NM141) Ophthalmic Solution In Healthy Adult Volunteers
Dose escalation 3+3 design with accelerated titration 4 dose levels
Read the 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.
- Conditions
- Corneal Epithelial Degeneration
- Being tested
- TTHX1114(NM141) Ophthalmic Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTHX1114(NM141) Ophthalmic SolutionDrug
Eye drop twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: TTHX1114(NM141) Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Important Medical Events (ocular) related to study treatment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start6 Dec 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trefoil Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Tremblay, Study director, Trefoil Therapeutics.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769920
- Sponsor's protocol ID
- NM141-001
- Acronym
- EPI
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TTHX1114(NM141) Ophthalmic Solution In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05769920
- Acronym / sponsor ID
- EPI / NM141-001
- Conditions
- Corneal Epithelial Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Trefoil Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TTHX1114 Dose Level 1 | Experimental | Drug: TTHX1114(NM141) Ophthalmic SolutionTTHX1114(NM141) Ophthalmic Solution (DL1): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days |
| TTHX1114 Dose Level 2 | Experimental | Drug: TTHX1114(NM141) Ophthalmic SolutionTTHX1114(NM141) Ophthalmic Solution (DL2): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days |
| TTHX1114 Dose Level 3 | Experimental | Drug: TTHX1114(NM141) Ophthalmic SolutionTTHX1114(NM141) Ophthalmic Solution (DL3): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days |
| TTHX1114 Dose Level 4 | Experimental | Drug: TTHX1114(NM141) Ophthalmic SolutionTTHX1114(NM141) Ophthalmic Solution (DL4): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTHX1114(NM141) Ophthalmic SolutionEye drop twice daily | Drug | TTHX1114 Dose Level 1, TTHX1114 Dose Level 2, TTHX1114 Dose Level 3, TTHX1114 Dose Level 4 |
Primary outcome
Dose Limiting Toxicity
Time frame: 28 days
Important Medical Events (ocular) related to study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Tremblay study director
Trefoil Therapeutics.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTHX1114(NM141) Ophthalmic Solution in people with Corneal Epithelial Degeneration, run by Trefoil Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.