Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Phase 1

Recruiting

• Conditions: Healthy Volunteers Essential Hypertension
• Interventions: Drug: Placebo; Drug: KK3910

• Registration Number: NCT06823947
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-12
• Status Verified: 2025-04
• Study Start: 2025-04-03
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KK3910	KK3910	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to the maximum concentration	Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155
The maximum concentration	Part 1 : Day 1 to Day 85, Part 2 : 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

Trial Locations

Locations (1)

Kitasato University Kitasato Institute Hospital; 🇯🇵 Minato-ku, Tokyo, Japan