Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

KK3910

Group Type EXPERIMENTAL

KK3910

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

KK3910

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes