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FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension

NCT04585100 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-07-20

No results posted yet for this study

Summary

A PHASE 1/2A, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, MULTI-CENTER STUDY ASSESSING THE SAFETY, TOLERABILITY, AND EFFICACY OF FM101 IN PATIENTS WITH OCULAR HYPERTENSION, AND TO ASSESS THE RELATIVE BIOAVAILABILITY OF THE FM101 ORAL TABLET FORMULATION IN HEALTHY PARTICIPANTS

Conditions

Interventions

DRUG

FM101 tablet

Bio-equivalent test (tablet vs oral solution)

DRUG

FM101 oral solution

Bio-equivalent test (tablet vs oral solution)

DRUG

Placebo

Placebo BID for 28 days

DRUG

FM101 150 mg

FM101 (150 mg) BID for 28 days

DRUG

FM101 300 mg

FM101 (300 mg) BID for 28 days

Sponsors & Collaborators

  • Futuremedicine Australia

    collaborator UNKNOWN

  • Future Medicine

    lead INDUSTRY

Principal Investigators

  • Jung Chul Kwon · Futuremedicine Australia Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2023-01-31
Completion
2023-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04585100 on ClinicalTrials.gov