Healthy Volunteers Clinical Trial
Official title:
A Phase I Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration
Verified date | May 2023 |
Source | Kyowa Kirin Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 116 |
Est. completion date | August 26, 2022 |
Est. primary completion date | August 26, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: Healthy Volunteers - Voluntary written informed consent to participate in the study - Japanese or white men 20 to < 50 years at the time of informed consent - BMI 18.5 to < 30.0 at screening - Intraocular pressure (study eye) 10.0 mm Hg to 21.0 mm Hg - Monocular or binocular visual acuity (corrected visual acuity if correction is required) = 1.0 at screening Inclusion Criteria: Patients - Voluntary written informed consent to participate in the study - Age = 50 years at the time of informed consent - 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 - CST = 300 µm in the study eye at screening, as measured by OCT - BCVA score = 23 letters in the study eye at screening and enrollment, as measured by the ETDRS visual acuity chart - BCVA score = 58 letters in the non-study eye at screening, as measured by the ETDRS visual acuity chart - 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 - Current illness requiring treatment - History of ophthalmologic laser surgery, ophthalmologic surgery, nasolacrimal duct surgery, orany eyelid surgery affecting flow in the nasolacrimal duct - History of or current circulatory disease (e.g., cerebrovascular or cardiovascular disease) - History of or current dry eye - Abnormal findings on OCT at screening or enrollment examination Exclusion Criteria: Patients - 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 - Any of the following diseases in the study eye: - Glaucoma - Ischemic optic neuropathy - Retinitis pigmentosa - Current or history of vitreous hemorrhage or macular hole in the study eye - 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Hakata clinic | Fukuoka |
Lead Sponsor | Collaborator |
---|---|
Kyowa Kirin Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated. | Day 1 to Day 43 | |
Secondary | 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 | ||
Secondary | Time to the maximum concentration | Day 1 to Day 43 | ||
Secondary | The maximum concentration | Day 1 to Day 43 | ||
Secondary | Area under the concentration-time curve | Day 1 to Day 43 | ||
Secondary | Apparent clearance | Day 1 to Day 43 | ||
Secondary | Elimination half-life | Day 1 to Day 43 |
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