Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

NCT06823947 | Recruiting Phase 1

• 1 other identifier: 3910-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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. Part 3 : To assess the safety profile of repeated dosing of KK3910 in an additional hypertension cohort.

Conditions

Healthy Volunteers Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

KK3910

EXPERIMENTAL

Drug: KK3910

Interventions

Placebo DRUG

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

Placebo

KK3910 DRUG

KK3910 is administered single dose or multiple dose by SC injection.

KK3910

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (3)

SOUSEIKAI PS Clinic

Hakata, Fukuoka, 812-0025, Japan

NOT YET RECRUITING

Medical Corporation Heishinkai OPHAC Hospital

Yodogawa, Osaka, 532-0003, Japan

NOT YET RECRUITING

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

RECRUITING

Study Officials

• Tatsuhiko Makine

  Kyowa Kirin Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Kyowa Kirin Co., Ltd.

CONTACT

+81-3-5205-7200; clinical.info.jp@kyowakirin.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)