A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration

Healthy Volunteers Clinical Trial

Official title:

A Phase I Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04594681
• Other study ID #: 4951-001
• Status: Terminated
• Phase: Phase 1
• Start date: September 16, 2020
• Est. completion date: August 26, 2022

Study information

• Verified date: May 2023
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy Volunteers
• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• Placebo
Placebo is administered once daily or three times daily.
• KHK4951
KHK4951 is administered once daily or three times daily.

Locations

Country	Name	City	State
Japan	Hakata clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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