RecruitingPhase 1NCT06823947

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


Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

160 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called KK3910, first in healthy volunteers to check safety, then in people with essential tremor — an uncontrolled shaking, usually of the hands, that is not caused by Parkinson's disease. **You may be eligible if...** - You are 18 or older - You have been diagnosed with essential tremor (or are a healthy volunteer for the first phase) - Your tremor is affecting your daily life - You are not currently taking medications that effectively control your tremor - You are generally healthy aside from your tremor **You may NOT be eligible if...** - You have Parkinson's disease or other neurological disorders causing tremor - You have serious heart, liver, or kidney disease - You have used certain medications or substances recently that could affect the results - You are pregnant or breastfeeding - You have had a serious allergic reaction to similar medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(3)

SOUSEIKAI PS Clinic

Hakata, Fukuoka, Japan

Medical Corporation Heishinkai OPHAC Hospital

Yodogawa, Osaka, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06823947