Healthy Volunteers Essential HypertensionPhase 1NCT06823947
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
A Phase 1 study testing KK3910 in people with Healthy Volunteers Essential Hypertension, run by Kyowa Kirin Co., Ltd. at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Essential Hypertension
- What is being tested?
- KK3910
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesJapan
- Study dates
- 3 Apr 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
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- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Not yet recruiting
SOUSEIKAI PS Clinic
Hakata, Fukuoka, 812-0025
Kyowa Kirin Co., Ltd., +81-3-5205-7200, clinical.info.jp@kyowakirin.com
- Recruiting
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642
Kyowa Kirin Co., Ltd., +81-3-5205-7200, clinical.info.jp@kyowakirin.com
- Not yet recruiting
Medical Corporation Heishinkai OPHAC Hospital
Yodogawa, Osaka, 532-0003
Kyowa Kirin Co., Ltd., +81-3-5205-7200, clinical.info.jp@kyowakirin.com
About this study
Official title: A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
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.
- Being tested
- Placebo, KK3910
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo is administered single dose or multiple dose by SC injection.
KK3910Drug
KK3910 is administered single dose or multiple dose by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KK3910 | Experimental | Not described Receives: Drug: KK3910 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.
Measured: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155
Secondary outcomes (3)
Time to the maximum concentration
Measured: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155
The maximum concentration
Measured: 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
Measured: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start3 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatsuhiko Makine, Study chair, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823947
- Sponsor's protocol ID
- 3910-001
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06823947
- Acronym / sponsor ID
- 3910-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| KK3910 | Experimental | Drug: KK3910 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo is administered single dose or multiple dose by SC injection. | Drug | Placebo |
| KK3910KK3910 is administered single dose or multiple dose by SC injection. | Drug | KK3910 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: 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.
3 secondary outcomes
Time to the maximum concentration
Time frame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155
The maximum concentration
Time frame: 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
Time frame: Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tatsuhiko Makine study chair
Kyowa Kirin Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KK3910 in people with Healthy Volunteers Essential Hypertension, run by Kyowa Kirin Co., Ltd. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyowa Kirin Co., Ltd. (+81-3-5205-7200, clinical.info.jp@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.