Health TrialsbyHealthPanel

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

ConditionHealthy Volunteers Essential Hypertension
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKyowa Kirin Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: KK3910Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

3

Map coordinates are unavailable for these locations. Locations are shown below instead.

SOUSEIKAI PS ClinicNot yet recruiting812-0025, Hakata, FukuokaJapanJapan
Medical Corporation Heishinkai OPHAC HospitalNot yet recruiting532-0003, Yodogawa, OsakaJapanJapan
Kitasato University Kitasato Institute HospitalRecruiting108-8642, Minato-ku, TokyoJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyowa Kirin Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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