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Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

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

NCT06823947•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

•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
•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
+10 more criteria

Locations (3)

SOUSEIKAI PS Clinic

Hakata, Fukuoka, Japan

Medical Corporation Heishinkai OPHAC Hospital

Yodogawa, Osaka, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Key Dates

Start Date

April 3, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 9, 2026

Enrollment

160

ESTIMATED participants

Conditions

Healthy Volunteers Essential Hypertension

Interventions

Placebo

DRUG

KK3910

DRUG

Contacts

Kyowa Kirin Co., Ltd.

CONTACT

+81-3-5205-7200 clinical.info.jp@kyowakirin.com