A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration
- Conditions
- Healthy VolunteersWet Age-related Macular Degeneration
- Interventions
- Drug: Placebo
- Registration Number
- NCT04594681
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 116
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo - KHK4951 KHK4951 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method The maximum concentration Day 1 to Day 43 Area under the concentration-time curve Day 1 to Day 43 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 Apparent clearance Day 1 to Day 43 Elimination half-life Day 1 to Day 43
Trial Locations
- Locations (1)
Hakata clinic
🇯🇵Fukuoka, Japan