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NCT07838220From ClinicalTrials.govRecruiting

A Study of IBI3016 in Japanese Participants

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of IBI3016 in Japanese Participants With Mild to Moderate Hypertension

  • Hypertension

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Enrolment target
30
Started
1 August 2026
Main results due
30 January 2027
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, Japan

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07838220. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of IBI3016 in Japanese Participants | Trialion