IBI3016 in Japanese adults with hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study evaluates safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous dose of IBI3016 in adults aged 18-75 who were born in Japan. Participants are assigned to one of four dose levels or placebo to characterize how the drug behaves in the body and its initial effects on blood pressure. Key eligibility requires Japanese origin and office-measured systolic BP between 140 and 170 mmHg at screening. Exclusion criteria include secondary hypertension, certain cardiovascular and RAAS-related conditions, and intolerance to related medications. The trial is conducted at a single site in Osaka under Innovent Biologics (Suzhou) Co. Ltd., with no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical Corporation Heishinkai OPHAC Hospital
  Osaka, Japan Recruiting

Study contacts

• Study coordinator: Wendy Duan
• Email: wenjing.duan@innoventbio.com
• Phone: +86 010-87412310

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.