Recruiting
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
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.
ClinicalTrials.gov IDNCT06823947
PhasePHASE1
Enrollment160
SponsorKyowa Kirin Co., Ltd.
Age18 Years
SexALL
Conditions studied
Healthy Volunteers Essential Hypertension
About this study
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.
Interventions
- Drug: Placebo — Placebo is administered single dose or multiple dose by SC injection.
- Drug: KK3910 — KK3910 is administered single dose or multiple dose by SC injection.
Primary outcomes
- Number of participants with adverse events (AEs) (Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155)
Eligibility information
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
Study locations
- SOUSEIKAI PS Clinic, Hakata, Fukuoka 812-0025 Japan
- Medical Corporation Heishinkai OPHAC Hospital, Yodogawa, Osaka 532-0003 Japan
- Kitasato University Kitasato Institute Hospital, Minato-ku, Tokyo 108-8642 Japan
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.