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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers Essential Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: KK3910

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kyowa Kirin Co., Ltd.; Phone Number: +81-3-5205-7200; Email: clinical.info.jp@kyowakirin.com

Study Locations

• Japan
  • Fukuoka
    • Hakata, Fukuoka, Japan, 812-0025
      • Not yet recruiting
      • SOUSEIKAI PS Clinic
      • Contact: Kyowa Kirin Co., Ltd.; Phone Number: +81-3-5205-7200; Email: clinical.info.jp@kyowakirin.com
  • Osaka
    • Yodogawa, Osaka, Japan, 532-0003
      • Not yet recruiting
      • Medical Corporation Heishinkai OPHAC Hospital
      • Contact: Kyowa Kirin Co., Ltd.; Phone Number: +81-3-5205-7200; Email: clinical.info.jp@kyowakirin.com
  • Tokyo
    • Minato-ku, Tokyo, Japan, 108-8642
      • Recruiting
      • Kitasato University Kitasato Institute Hospital
      • Contact: Kyowa Kirin Co., Ltd.; Phone Number: +81-3-5205-7200; Email: clinical.info.jp@kyowakirin.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo is administered single dose or multiple dose by SC injection.
Experimental: KK3910	Drug: KK3910; KK3910 is administered single dose or multiple dose by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.	Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to the maximum concentration	Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155
The maximum concentration	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	Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.
• Investigators: Study Chair: Tatsuhiko Makine, Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension
• Other Study ID Numbers: 3910-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No