Trials / Unknown
UnknownNCT04585100
FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension
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
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Future Medicine · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-10-07
- Primary completion
- 2023-01-31
- Completion
- 2023-06-30
- First posted
- 2020-10-14
- Last updated
- 2022-07-20
Locations
5 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT04585100. Inclusion in this directory is not an endorsement.