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Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension. Part 3 : To assess the safety profile of repeated dosing of KK3910 in an additional hypertension cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| KK3910 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo is administered single dose or multiple dose by SC injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated. | Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the maximum concentration | Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155 | |
| The maximum concentration | Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155 |
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Inclusion Criteria: Part 1
Inclusion Criteria: Part 2
Inclusion Criteria: Part 3
Exclusion Criteria: Part 1
Exclusion Criteria: Part 2
Exclusion Criteria: Part 3
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyowa Kirin Co., Ltd. | Contact | +81-3-5205-7200 | clinical.info.jp@kyowakirin.com |
| Name | Affiliation | Role |
|---|---|---|
| Tatsuhiko Makine | Kyowa Kirin Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI PS Clinic | Not yet recruiting | Hakata | Fukuoka | 812-0025 | Japan |
There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
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| KK3910 |
| Drug |
KK3910 is administered single dose or multiple dose by SC injection. |
|
| Area under the concentration-Time curve | Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155 |
| Medical Corporation Heishinkai OPHAC Hospital | Not yet recruiting | Yodogawa | Osaka | 532-0003 | Japan |
|
| Kitasato University Kitasato Institute Hospital | Recruiting | Minato-ku | Tokyo | 108-8642 | Japan |
|