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RecruitingPhase 1NCT06823947

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

Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

160 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Essential Hypertension

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

  • 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
  • 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
  • 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 Criteria20

  • 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
  • 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
  • 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

Interventions

DRUGPlacebo

Placebo is administered single dose or multiple dose by SC injection.

DRUGKK3910

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

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NCT06823947