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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06823947

Enrollment

160

Registered

2025-02-12

Start date

2025-04-03

Completion date

2027-12-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers Essential Hypertension

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Part 1 * Voluntary consent to participate in this study must be given (in writing) * Japanese healthy adults or non-Asian healthy men 18 to \< 55 years at the time of informed consent ( Japanese healthy adults 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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events (AEs)	Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: 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

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

Countries

Japan

Contacts

CONTACTKyowa Kirin Co., Ltd.

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

STUDY_CHAIRTatsuhiko Makine

Kyowa Kirin Co., Ltd.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026