Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
Recruiting · NCT06823947 · Interventional (participants receive a specific treatment) · Lead sponsor: Kyowa Kirin Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
KK3910Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
3 locations listed.
- SOUSEIKAI PS Clinic - Hakata, Fukuoka, Japan
- Medical Corporation Heishinkai OPHAC Hospital - Yodogawa, Osaka, Japan
- Kitasato University Kitasato Institute Hospital - Minato-ku, Tokyo, Japan