A Phase 1 interventional study of Placebo and KK3910 in Healthy Volunteers Essential Hypertension, sponsored by Kyowa Kirin Co., Ltd.. Recruiting at 3 sites in Japan. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment
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.
478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.
This study's planned enrollment of 160 is above the median of 144 across 406 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Part 1
Inclusion Criteria: Part 2
Inclusion Criteria: Part 3
Exclusion Criteria: Part 1
Exclusion Criteria: Part 2
Exclusion Criteria: Part 3
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
Drug: KK3910
Placebo is administered single dose or multiple dose by SC injection.
KK3910 is administered single dose or multiple dose by SC injection.
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.
Time frame: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155
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
Plan to share: 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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
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