Clinical trial NCT06823947: Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers Essential Hypertension
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155
Secondary outcomes:
measure: Time to the maximum concentration
timeFrame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155
measure: The maximum concentration
timeFrame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155
measure: Area under the concentration-Time curve
timeFrame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Tatsuhiko Makine
role: STUDY_CHAIR
References: