Evaluating KK3910 in Healthy Volunteers and Patients with High Blood Pressure
Official title: A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
Run by Kyowa Kirin Co., Ltd. · NCT06823947 · Data updated 2026-11-12
This study is testing the safety of a new medication called KK3910 in healthy young men and in patients with high blood pressure to see how it affects their health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Locations | 3 sites (Hakata, Fukuoka and 2 other locations) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06823947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include Japanese patients aged 18 to under 65 years with essential hypertension.
✕Probably not a fit
Patients with a history of significant health issues or those outside the specified age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety of a single dose of KK3910 in healthy volunteers and a multiple dose in patients with essential hypertension. The trial is divided into two parts: the first part focuses on healthy Japanese or non-Asian men aged 18 to under 55 years, and the second part involves Japanese patients with essential hypertension aged 18 to under 65 years. Participants will receive either KK3910 or a placebo, and their health will be monitored throughout the study to evaluate any adverse effects.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with essential hypertension.
How similar studies have gone: While this approach is being tested in this specific context, similar studies evaluating new treatments for hypertension have shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan Recruiting -
SOUSEIKAI PS Clinic
Hakata, Fukuoka, Japan Not yet recruiting -
Medical Corporation Heishinkai OPHAC Hospital
Yodogawa, Osaka, Japan Not yet recruiting
Study contacts
- Study coordinator: Kyowa Kirin Co., Ltd.
- Email: clinical.info.jp@kyowakirin.com
- Phone: +81-3-5205-7200
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exploring the treatment LTP001 in healthy individuals and those with pulmonary arterial hypertension
This study is testing a new treatment called LTP001 in healthy people and those with pulmonary arterial hypertension to see how safe it is and if it can help improve their condition.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.