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Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 2 wordsv5
  2. Notable Primary and study completion dates: Mar 2027 to Dec 2027v4 Show 4 more changesShow less
    • Enrollment target: 144 to 160
    • Study sites: 1 to 3
    • Eligibility criteria expanded, about 132 words
    • Secondary endpoints: details revised at 3 of 3 entries
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 19, 2025 to Apr 3, 2025
    v3
  4. Minor Secondary endpoints: 4 to 3
    • Study title shortened, about 3 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06823947
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)
Healthy Volunteers Essential Hypertension
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov