MedTrace Logo

Safety, Tolerability and Pharmacokinetics of Felbinac Trometamol Eye Drops

NCT05085106 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-10-20

No results posted yet for this study

Summary

To evaluate the safety and tolerability of felbinac trometamol eye drops of single-dose, multiple-dose, dose escalation in healthy subjects, for providing the basis for the dose setting in the later clinical study.

Conditions

  • Healthy

Interventions

DRUG

Felbinac trometamol eye drop

Felbinac trometamol eye drop: 0.025%、0.05%、0.1%、0.2%、0.3%, 1 drop will be instilled as instructed over one day in single-dose study; 0.1%, 0.2%, 1 drop per time, four times each day and for seven days totally in multiple-dose study.

DRUG

Placebo eye drop

Placebo eye drop: 0.0%, 1 drop will be instilled as instructed over one day in single-dose study; 0.0%, 1 drop per time, four times each day and for seven days totally in multiple-dose study.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Xiuli Zhao, Ph.D. · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085106 on ClinicalTrials.gov