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A Study of IBI3016 in Japanese Participants

RecruitingPhase 1Ages 18 Years - 75 YearsAllInnovent Biologics (Suzhou) Co. Ltd.
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In plain words

What the trial is, and whether it could suit you

A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 1\. Male or female participants aged 18-75 years (inclusive) at the time of informed consent; * 2\. Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin; * 3\. Office mean sitting SBPโ‰ฅ 140 mmHg and \< 170 mmHg at screening Exclusion Criteria: * 1\. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea; * 2\. History of orthostatic hypotension * 3\. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor * 4\. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening; * 5\. Presence of serious active and uncontrolled physical conditions or medical history, which may be in a dangerous state during the use of the study drug, or interfere with the interpretation of efficacy and safety data of this study, as judged by the investigator prior to randomization
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What it tests

  • IBI3016 Dose 4
  • IBI3016 Dose 3
  • IBI3016 Dose 2
  • IBI3016 Dose 1
  • Placebo
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Where

1 site
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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