Ocular HypertensionPhase 1/2NCT04585100
FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension
A Phase 1/2 study testing FM101 tablet, FM101 oral solution and FM101 150 mg in people with Ocular Hypertension, run by Future Medicine at 5 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- FM101 tablet, FM101 oral solution and FM101 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesAustralia
- Study dates
- 7 Oct 2020to 30 Jun 2023
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex : Male or female patients.
- Age : 18 to 75 years, inclusive, at screening.
- BMI : 18.0 to 32.0 kg/m2.
- Weight : ≥50 kg.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until study completion, including the follow-up period for at least 90 days after the last dose of study drug, or be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of FSH levels (≥30 IU/mL) at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
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- Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse will also be eligible. Male participants must agree to refrain from donating sperm from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug.
- Willing and able to participate in the study, give written informed consent, and comply with the study procedures.
- Diagnosis of OHT in at least 1 eye, not currently receiving medication for raised IOP or able to stop such medication for a washout period and the duration of the study.
- Elevated IOP (≥24 and ≤32 mmHg at 08:00 hours, and ≥21 and ≤32 mmHg at 12:00 hours) on baseline visit in at least one eye off treatment.
- Anterior chamber is open and non-occludable (both eyes) as confirmed by Investigator by gonioscopy examination at screening.
Who cannot join
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the patient.
- Female patients who are pregnant, nursing, or planning a pregnancy. The absence of pregnancy will be confirmed for all female patients by a serum pregnancy test conducted at screening, and a urine pregnancy test on Day -1 and at follow-up.
- Patients with known or suspected drug or alcohol abuse.
- Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any type of medical research.
- Patients with a history of poor study drug compliance, protocol non-compliance, or prohibited medication intake.
- Patients with a history or presence of uncontrolled, chronic, generalized, systemic, or other disease that the Investigator feels might increase the risk to the safety of the patient or confound the results of the study.
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- Surgery (e.g., stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Patients requiring concomitant medication (either systemic or topical) known to affect IOP (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, CAIs, or corticosteroids). However, systemic antihypertensive medications are allowed as long as the dose and regimen have been stable for at least 3 months prior to screening and are expected to remain stable throughout the study.
- Receiving more than one medication for IOP at time of screening.
- Patients who used inhibitors or inducers of cytochrome P450 3A4 in the last 30 days.
- Uncontrolled intraocular hypertension in any eye defined as >30 mmHg at either of the screening/baseline visits (after a washout phase in those patients who were currently receiving ocular hypotensive therapy).
- Central corneal thickness of less than 500 µm or greater than 620 µm.
- BCVA worse than 20/200 in either eye.
- Any corneal abnormality or other condition interfering or preventing reliable Goldmann applanation tonometry (e.g., Fuchs dystrophy or significant corneal surface abnormality).
- Advanced glaucoma (e.g., cup/disc ratio >0.80), evidence of significant visual field defect that would be at risk for progression during the wait/washout period, or progressive visual field loss within the last year.
- Any other forms of glaucoma (e.g angle closure glaucoma, normal tension glaucoma, congenital glaucoma, etc), other than OAG or OHT.
- Use of contact lenses within one week prior to Day 1 until end of treatment.
- Patients with history of severe ocular trauma in either eye.
- Previous complicated surgery or glaucoma surgery or laser treatment of any kind in either eye.
- Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids.
- History of retinal detachment, proliferative diabetic retinopathy, or any retinal disease that may be progressive during the time course of the study.
- Presence of clinically significant macular edema.
- Any ocular disease or condition that in the opinion of the study Investigator may put the patient at significant risk, may confound study results, or may interfere significantly with the patient's participation in the study.
- Donation or loss of more than 450 mL blood during the 3 months before the start of screening.
- Known allergy, hypersensitivity, or contraindications to FM101.
- Positive screen for HBsAg, HCV antibodies, or anti-HIV 1 and 2 antibodies.
- Any other condition that would confound the study or endanger the safety of the patient as per the judgment of the Investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites, 4 recruiting
- Recruiting
Adelaide Eye & Retina Centre
Adelaide
Jagjit (Jolly) S Gilhotra, Dr, +61 8 8212 3022
- Completed
CMAX Clinical Research Pty Ltd
Adelaide
- Recruiting
Norwest Eye Medical Pty Ltd
Bella Vista, New South Wales
Tariq Yasser, Dr
- Recruiting
Eye Surgery Associates
East Melbourne
Nathan Kerr, Dr, +61 3 9998 8337
- Recruiting
Lions Eye Institute
Nedlands
Antony Clark, Dr
About this study
Official title: 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
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
- Ocular Hypertension
- Being tested
- FM101 tablet, FM101 oral solution, Placebo, FM101 150 mg, FM101 300 mg
- Keywords
- Ocular Hypertension, OHT, FM101
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM101 tabletDrug
Bio-equivalent test (tablet vs oral solution)
FM101 oral solutionDrug
Bio-equivalent test (tablet vs oral solution)
PlaceboDrug
Placebo BID for 28 days
FM101 150 mgDrug
FM101 (150 mg) BID for 28 days
FM101 300 mgDrug
FM101 (300 mg) BID for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Bioequivalent test of FM101 oral solution and FM101 tablet | Experimental | Not described Receives: Drug: FM101 tablet; Drug: FM101 oral solution |
| Phase 2a | Experimental | Not described Receives: Drug: Placebo; Drug: FM101 150 mg; Drug: FM101 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of two dose levels of FM101 after repeated dosing in patients with OAG or OHT compared to that of placebo.
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
Measured: Day 1 through Day 37
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 08:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
IOP change in the study eye at 8:00 from Baseline to Day 28
Measured: Day 1 through Day 28
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 12:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
IOP change in the study eye at 12:00 from Baseline to Day 28
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start7 Oct 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Futuremedicine Australia
- Responsible party
- Sponsor
- Investigators
- Jung Chul Kwon, Study chair, Futuremedicine Australia Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585100
- Sponsor's protocol ID
- FM101-CTP2-002
- Status last verified
- Dec 2021
- First submitted
- 7 Sep 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04585100
- Acronym / sponsor ID
- FM101-CTP2-002
- Conditions
- Ocular Hypertension
- Keywords
- Ocular Hypertension, OHT, FM101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Future MedicineIndustry (pharma, biotech, devices)
- Collaborators
- Futuremedicine Australia
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 Oct 2020 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioequivalent test of FM101 oral solution and FM101 tablet | Experimental | Drug: FM101 tablet, Drug: FM101 oral solution |
| Phase 2a | Experimental | Drug: Placebo, Drug: FM101 150 mg, Drug: FM101 300 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sex : Male or female patients.
- Age : 18 to 75 years, inclusive, at screening.
- BMI : 18.0 to 32.0 kg/m2.
- Weight : ≥50 kg.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until study completion, including the follow-up period for at least 90 days after the last dose of study drug, or be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of FSH levels (≥30 IU/mL) at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
Key exclusion criteria (28 listed)
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the patient.
- Female patients who are pregnant, nursing, or planning a pregnancy. The absence of pregnancy will be confirmed for all female patients by a serum pregnancy test conducted at screening, and a urine pregnancy test on Day -1 and at follow-up.
- Patients with known or suspected drug or alcohol abuse.
- Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any type of medical research.
- Patients with a history of poor study drug compliance, protocol non-compliance, or prohibited medication intake.
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 |
|---|---|---|
| FM101 tabletBio-equivalent test (tablet vs oral solution) | Drug | Bioequivalent test of FM101 oral solution and FM101 tablet |
| FM101 oral solutionBio-equivalent test (tablet vs oral solution) | Drug | Bioequivalent test of FM101 oral solution and FM101 tablet |
| PlaceboPlacebo BID for 28 days | Drug | Phase 2a |
| FM101 150 mgFM101 (150 mg) BID for 28 days | Drug | Phase 2a |
| FM101 300 mgFM101 (300 mg) BID for 28 days | Drug | Phase 2a |
Primary outcome
To assess the safety and tolerability of two dose levels of FM101 after repeated dosing in patients with OAG or OHT compared to that of placebo.
Time frame: Day 1 through Day 37
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 08:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
Time frame: Day 1 through Day 28
IOP change in the study eye at 8:00 from Baseline to Day 28
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 12:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
Time frame: Day 1 through Day 28
IOP change in the study eye at 12:00 from Baseline to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
Jung Chul Kwon study chair
Futuremedicine Australia Pty Ltd
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FM101 tablet, FM101 oral solution and FM101 150 mg in people with Ocular Hypertension, run by Future Medicine at 5 sites in Australia.
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 11 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyunghee Kim (+82222898540, kkh@futuremedicine.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of two dose levels of FM101 after repeated dosing in patients with OAG or OHT compared to that of placebo. (time frame: Day 1 through Day 37). The study lists 3 primary outcomes in all. 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 20 Jul 2022.