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Clinical Trials in Japan / NCT06823947
Recruiting Phase 1

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

NCT06823947 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2025-04-03
Last updated
2026-07-01

Condition(s) studied

Healthy Volunteers Essential Hypertension

Investigational drug(s) / intervention(s)

PlaceboKK3910

Placebo: Placebo is administered single dose or multiple dose by SC injection.

KK3910: KK3910 is administered single dose or multiple dose by SC injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: 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 Inclusion Criteria: 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 Inclusion Criteria: 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 Exclusion Criteria: 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 Exclusion Criteria: 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 Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
SOUSEIKAI PS Clinic Hakata Fukuoka Not Yet Recruiting
Medical Corporation Heishinkai OPHAC Hospital Yodogawa Osaka Not Yet Recruiting
Kitasato University Kitasato Institute Hospital Minato-ku Tokyo Recruiting

More Kyowa Kirin Co., Ltd. trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06823947 on ClinicalTrials.gov ↗ ← All trials in Japan