RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify: Part 1
- Voluntary consent to participate in this study must be given (in writing)
- Japanese or non-Asian healthy men 18 to \< 55 years at the time of willing to sign a consent form ( Japanese healthy men 65 to \< 80 years for the elderly cohort)
- BMI is within the specified range at screening
Who May Qualify: 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 willing to sign a consent form
- BMI is within the specified range at screening
Who May Qualify: 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 willing to sign a consent form
- BMI is within the specified range at screening
Who Should NOT Join This Trial: Part 1
- History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune conditions (where your immune system attacks your own body), 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
Who Should NOT Join This Trial: Part 2
- History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune conditions (where your immune system attacks your own body), 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria: Part 1
* Voluntary consent to participate in this study must be given (in writing)
* Japanese or non-Asian healthy men 18 to \< 55 years at the time of informed consent ( Japanese healthy men 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
Treatments Being Tested
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.
Locations (3)
SOUSEIKAI PS Clinic
Hakata, Fukuoka, Japan
Medical Corporation Heishinkai OPHAC Hospital
Yodogawa, Osaka, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan