臨床研究等提出・公開システム

A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients with Essential Hypertension

A Phase 1 Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneous KK3910 Compared with Placebo in Healthy Volunteers and Patients with Essential Hypertension

Makine Tatsuhiko

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi, Chiyoda-ku, Tokyo

clinical.info.jp@kyowakirin.com

Clinical trial information contact

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi, Chiyoda-ku, Tokyo

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

Recruiting

April. 03, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Part 1:
- Voluntary consent to participate in this study must be given (in writing)
- Japanese healthy adults or non-Asian healthy men 18 to < 55 years at the time of informed consent (Japanese healthy adults 65 to < 80 years for the elderly cohort)
- BMI is within the specified range at screening

Part 2:
- Voluntary consent to participate in this study must be given (in writing)
- Japanese patients with essential hypertension, aged 18 to <65 years at the time of informed consent
- BMI is within the specified range at screening

Part 3:
- Voluntary consent to participate in this study must be given (in writing)
- Japanese patients with essential hypertension, aged 18 to <80 years at the time of informed consent
- BMI is within the specified range at screening

Part 1:
- History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- History of or current drug allergy
- History of or current alcoholism or drug addiction
- Smoking within the specified period
- infection within the specified period
- Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Part 2:
- History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- History or of current drug allergy
- History of or current alcoholism or drug addiction
- Pregnant or breastfeeding patients, or patients willing to have a child during the study
- Smoking within the specified period
- infection within the specified period
- Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Part 3:
- History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- History or of current drug allergy
- History of or current alcoholism or drug addiction
- Pregnant or breastfeeding patients, or patients willing to have a child during the study
- Smoking within the specified period
- infection within the specified period
- Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Both

Essential hypertension

<Part 1> A single SC administration of KK3910 or placebo
<Part 2> Repeated SC administration of KK3910 or placebo
<Part 3> Repeated SC administration of KK3910 or placebo

Number of participants with adverse events

-Profile of pharmacokinetics of serum KK3910 concentration
-Time to the maximum concentration
-the maximum concentration
-Area under the concentration-Time curve

+81-3-5791-6177

Mar. 27, 2025

Yes

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.

none