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

Primary Purpose

Healthy Volunteers, Wet Age-related Macular Degeneration

Status

Terminated

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Placebo

KHK4951

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hakata clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

KHK4951

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum KHK4951 concentration

Time to the maximum concentration

The maximum concentration

Area under the concentration-time curve

Apparent clearance

Elimination half-life

Full Information

NCT ID

NCT04594681

First Posted

September 22, 2020

Last Updated

May 16, 2023

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04594681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

The Sponsor judged that the objectives of this Phase 1 study were satisfied, and the study was terminated after the completion of Cohort 3 Step 3.

Study Start Date

September 16, 2020 (Actual)

Primary Completion Date

August 26, 2022 (Actual)

Study Completion Date

August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Wet Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

KHK4951

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo is administered once daily or three times daily.

Intervention Type

Drug

Intervention Name(s)

KHK4951

Intervention Description

KHK4951 is administered once daily or three times daily.

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.

Time Frame

Day 1 to Day 43

Secondary Outcome Measure Information:

Title

Serum KHK4951 concentration

Time Frame

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

Title

Time to the maximum concentration

Time Frame

Day 1 to Day 43

Title

The maximum concentration

Time Frame

Day 1 to Day 43

Title

Area under the concentration-time curve

Time Frame

Day 1 to Day 43

Title

Apparent clearance

Time Frame

Day 1 to Day 43

Title

Elimination half-life

Time Frame

Day 1 to Day 43

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hakata clinic

City

Fukuoka

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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