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Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

NCT06823947 — Phase 1, Recruiting, 160 participants, Kyowa Kirin Co., Ltd.

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

RegistryNCT06823947
StatusRecruiting
PhasePhase 1
Study typeInterventional; randomized, sequential, masking: triple, treatment
Enrollment160 (Estimated)
SponsorKyowa Kirin Co., Ltd. (Industry)
ConditionsHealthy Volunteers Essential Hypertension
InterventionsPlacebo, KK3910 (Drug)
Datesstart 2025-04-03, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2025-02-12, last updated 2026-07-01
Locations3 sites in Japan

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
PlaceboPlacebo comparatorDrug: Placebo
KK3910ExperimentalDrug: KK3910
  • Placebo (Drug): Placebo is administered single dose or multiple dose by SC injection.
  • KK3910 (Drug): KK3910 is administered single dose or multiple dose by SC injection.

+Outcome measures

Primary outcomes

  • Number of participants with adverse events (AEs) [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.

Secondary outcomes

  • Time to the maximum concentration [Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]
  • The maximum concentration [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 [Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155]

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria: Part 1

* 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

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

+Locations (3)

FacilityCityCountryStatus
SOUSEIKAI PS ClinicHakata, FukuokaJapanNot yet recruiting
Medical Corporation Heishinkai OPHAC HospitalYodogawa, OsakaJapanNot yet recruiting
Kitasato University Kitasato Institute HospitalMinato-ku, TokyoJapanRecruiting

+Investigators

My Notes