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Recruiting
NCT07838220
A Study of IBI3016 in Japanese Participants
Conditions: Hypertension
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Location: Medical Corporation Heishinkai OPHAC Hospital Osaka
Summary
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.
Eligibility Criteria
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 SBP≥ 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
Source: ClinicalTrials.gov (NCT07838220). StuddyBuddy aggregates publicly available trial information.