Recruiting NCT06823947
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, KK3910.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers Essential Hypertension. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of participants with adverse events (AEs) [Time frame: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155]
Secondary outcome measures (3)
- Time to the maximum concentration [Time frame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]
- The maximum concentration [Time frame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]
- Area under the concentration-Time curve [Time frame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Japan · 3 centers
- SOUSEIKAI PS Clinic — Hakata
- Medical Corporation Heishinkai OPHAC Hospital — Yodogawa
- Kitasato University Kitasato Institute Hospital — Minato-ku
Identifiers
NCT: NCT06823947 · 3910-001