Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Q: What is the NCT06823947 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT06823947?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06823947?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension (NCT06823947) is a Phase 1 interventional studying Healthy Volunteers Essential Hypertension, sponsored by Kyowa Kirin Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Healthy Volunteers Essential Hypertension, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Healthy Volunteers Essential Hypertension subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form ( Japanese healthy men 65 to \< 80 years for the elderly cohort) - BMI is within the specified range at screening Who May Qualify: 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 willing to sign a consent form - BMI is within the specified range at screening Who May Qualify: 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 willing to sign a consent form - BMI is within the specified range at screening Who Should NOT Join This Trial: Part 1 - History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune conditions (where your immune system attacks your own body), 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 Who Should NOT Join This Trial: Part 2 - History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune conditions (where your immune system attacks your own body), 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 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 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 Exclusion Criteria: Part 3 * 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

Treatments Being Tested

DRUG

Placebo

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

DRUG

KK3910

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

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

SOUSEIKAI PS Clinic

Hakata, Fukuoka, Japan

Medical Corporation Heishinkai OPHAC Hospital

Yodogawa, Osaka, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06823947), the sponsor (Kyowa Kirin Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06823947 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06823947?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06823947?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06823947. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06823947. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.