A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate safety and tolerability after administration of KHK4951 in healthy volunteers and patients with wet age-related macular degeneration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo is administered once daily or three times daily.
|
| Experimental: KHK4951
|
Drug: KHK4951
KHK4951 is administered once daily or three times daily.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events [Day 1 to Day 43]
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.
Secondary Outcome Measures
- Serum KHK4951 concentration [Healthy Volunteers: Day 1, Day2, Day4, Day8, Day12, Day16, Day21, Day23, Day 25, Day 29, Day 36, Day 43; Patients: Day 1, 8, 22, 43]
- Time to the maximum concentration [Day 1 to Day 43]
- The maximum concentration [Day 1 to Day 43]
- Area under the concentration-time curve [Day 1 to Day 43]
- Apparent clearance [Day 1 to Day 43]
- Elimination half-life [Day 1 to Day 43]
Eligibility Criteria
Criteria
Inclusion Criteria: Healthy Volunteers
-
Voluntary written informed consent to participate in the study
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Japanese or white men 20 to < 50 years at the time of informed consent
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BMI 18.5 to < 30.0 at screening
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Intraocular pressure (study eye) 10.0 mm Hg to 21.0 mm Hg
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Monocular or binocular visual acuity (corrected visual acuity if correction is required) ≥ 1.0 at screening
Inclusion Criteria: Patients
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Voluntary written informed consent to participate in the study
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Age ≥ 50 years at the time of informed consent
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AMD-associated by active subfoveal CNV lesions in the study eye or juxtafoveal CNV lesions with CNV-associated findings in the fovea in the study eye
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CST ≥ 300 μm in the study eye at screening, as measured by OCT
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BCVA score ≥ 23 letters in the study eye at screening and enrollment, as measured by the ETDRS visual acuity chart
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BCVA score ≥ 58 letters in the non-study eye at screening, as measured by the ETDRS visual acuity chart
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In subjects with prior treatment of the study eye with anti-vascular endothelial growth factor (anti-VEGF) drugs such as Beovu, Eylea, Lucentis, Avastin, or Macugen, presence of response to the anti-VEGF drug(s) as judged by the investigator or subinvestigator based OCT, FA, visual acuity, or other assessment results
Exclusion Criteria: Healthy Volunteers
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Current illness requiring treatment
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History of ophthalmologic laser surgery, ophthalmologic surgery, nasolacrimal duct surgery, orany eyelid surgery affecting flow in the nasolacrimal duct
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History of or current circulatory disease (e.g., cerebrovascular or cardiovascular disease)
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History of or current dry eye
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Abnormal findings on OCT at screening or enrollment examination
Exclusion Criteria: Patients
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Clinical findings or a history of conditions other than wAMD affecting the retina and choroid (e.g., diabetic retinopathy, diabetic macular edema, myopic CNV, retinal vein occlusion, or premacular membrane) in either of the eyes
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Any of the following diseases in the study eye:
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Glaucoma
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Ischemic optic neuropathy
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Retinitis pigmentosa
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Current or history of vitreous hemorrhage or macular hole in the study eye
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Any abnormality in the anterior segment of the eye or vitreous body that may affect fundus observation by OCT, color fundus photography, or fluorescein angiography
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hakata clinic | Fukuoka | Japan |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4951-001