NCT05769920

Dose Escalation TTHX1114 Ophthalmic Solution

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Trefoil Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Corneal Epithelial Degeneration

Interventions

Type	Name	Description
DRUG	TTHX1114(NM141) Ophthalmic Solution	Eye drop twice daily

Timeline

• Start date: 2022-12-06
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2023-03-15
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study