Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension (NCT06823947) | Clinical Trial Compass
RecruitingPhase 1
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
Japan160 participantsStarted 2025-04-03
Plain-language summary
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 participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155