Clinical trial NCT05456724: A Study to Investigate the Effect of IOP-lowering With TO-O-1001 Eye Drops in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A 3-Part, First-in-human, Double-Blind, Randomized, and Placebo-Controlled Study Assessing the Safety, Tolerability, and Efficacy of TO-O-1001 Ophthalmic Solution in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Metagone Biotech Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2022-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I/II stage to investigate the safety, tolerability, and ocular hypotensive efficacy of TO-O-1001 in healthy volunteers and patients with Open-Angle Glaucoma or Ocular Hypertension.

The proposed trial consists of 3 study parts to be conducted at Nucleus Network Melbourne.

This study will enroll up to 34 evaluable healthy volunteers in part 1(SAD) and part 2(MD) and 16 evaluable patients with Open-Angle Glaucoma or Ocular Hypertension in part 3(MD).

Note- As of 14Mar2023, enrolment has been completed for Part 1 and Part 2 and recruitment is pending now for Part 3.


Eligibility criteria: Inclusion Criteria:

For Healthy Subjects (Parts 1 \& 2)

1. 18 - 59-year-old healthy male or female subjects who are non-lactating and non-pregnant.
2. BMI 18.0\~32.0(kg/m2) and body weight more than 45kg.
3. Intraocular pressure between 10 - 21 mm Hg (inclusive) in each eye.
4. Best-corrected visual acuity (BCVA) in each eye of 20/40 ETRDS or better.
5. The informed consent form has been read, signed and dated by the subjects.
6. Able to communicate well with the investigator and comply with the requirements of the study.

For Patients (Part 3)

1. Must be 18 years of age or older.
2. Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT).
3. Unmedicated or after washout intraocular pressure (IOP) \>20 mmHg and \< 30 mmHg in study eye at T0 (T0 = 08:00AM\~10:00 AM) of the first qualification visit (Day 1).
4. Best-corrected visual acuity (BCVA) equivalent to 20/200 ETRDS or better.
5. The informed consent form has been read, signed and dated by the subjects.
6. Able to communicate well with the investigator and comply with the requirements of the study

Exclusion Criteria:

For Healthy Subjects (Parts 1 \& 2)

1. Subjects has chronic or acute ophthalmic disease including glaucoma, macular degeneration, and clinically significant cataract (primary or secondary).
2. Subjects has previous glaucoma intraocular surgery or glaucoma laser procedures within 3 years.
3. Subjects has refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) within 5 years.
4. Subjects has ocular trauma within the past 6 months, or ocular surgery or laser treatment within the past three months (e.g., laser treatment for glaucoma or retina).

For Patients (Part 3)

1. Closed or very narrow angles (Grade 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laser iridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAS criteria are still met).
2. Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALT or SLT) in either eye is allowed if performed more than 6 months prior to Screening Visit.
3. Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in either eye.
4. Participation in a clinical study with use of any investigational drug or treatment within 28 days prior to Baseline (Day 1).
5. Clinically significant abnormalities in: laboratory tests, physical examination, vital signs and/or ECG at Screening Visit. If in the investigator's judgment a subjects with clinically significant abnormalities is appropriate for enrollment in the study, a discussion between the investigator and the Medical Monitor must occur and be documented prior to enrollment of this subjects in the study.

Primary outcomes:
measure: Safety and tolerability of TO-O-1001 though the incidence of adverse events.
timeFrame: Up to 28 days
measure: Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
timeFrame: Up to 28 days
Secondary outcomes:
measure: Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
timeFrame: Up to 8 days
measure: Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
timeFrame: Up to 8 days
measure: Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
timeFrame: Up to 8 days
measure: Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
timeFrame: Up to 8 days
measure: Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
timeFrame: Up to 8 days
measure: Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
timeFrame: Up to 8 days
measure: Best Corrected Visual Acuity (BCVA) of TO-O-1001.
timeFrame: Up to 28 days
measure: Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Melbourne
state: Victoria
Study officials:
affiliation: Nucleus Network Melbourne
name: Sam Francis
role: PRINCIPAL_INVESTIGATOR
References: