A Phase 1 Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneous KK3910 Compared with Placebo 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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240676

Enrollment

144

Registered

2025-02-14

Start date

2025-04-17

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential hypertension

Interventions

A single SC administration of KK3910 or placebo Repeated SC administration of KK3910 or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	—

Secondary

Measure	Time frame
-Profile of pharmacokinetics of serum KK3910 concentration -Time to the maximum concentration -the maximum concentration -Area under the concentration-Time curve	—

Contacts

Public ContactClinical trial information contact

Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com+81-3-5205-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026