Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Kyowa Kirin

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers Essential Hypertension

Treatments: Drug: Placebo; Drug: KK3910

Study type: Interventional

Funder types: Industry

Identifiers

NCT06823947

3910-001

Details and patient eligibility

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

144 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

KK3910

Experimental group

Treatment:

Drug: KK3910