NCT06823947RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 7 Feb 2025
- Start date
- Apr 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT06823947
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From Apr 2025 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
- 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
- infection within the specified period
- Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
Other
- Smoking within the specified period
- Pregnant or breastfeeding patients, or patients willing to have a child during the study
- Smoking within the specified period
- Pregnant or breastfeeding patients, or patients willing to have a child during the study
- Smoking within the specified period
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SOUSEIKAI PS Clinic Coordinator of this site? Confirm its status | Hakata | Japan | Not yet recruiting |
| Kitasato University Kitasato Institute Hospital Coordinator of this site? Confirm its status | Minato-ku | Japan | Recruiting |
| Medical Corporation Heishinkai OPHAC Hospital Coordinator of this site? Confirm its status | Yodogawa | Japan | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.