Recruiting
A Study of IBI3016 in Japanese Participants
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.
ClinicalTrials.gov IDNCT07838220
PhasePHASE1
Enrollment30
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Age18 Years
SexALL
Conditions studied
Hypertension
About this study
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.
Interventions
- Drug: IBI3016 Dose 4 — single doses of IBI3016 administered by subcutaneous injection
- Drug: IBI3016 Dose 3 — single doses of IBI3016 administered by subcutaneous injection
- Drug: IBI3016 Dose 2 — single doses of IBI3016 administered by subcutaneous injection
- Drug: IBI3016 Dose 1 — single doses of IBI3016 administered by subcutaneous injection
- Drug: Placebo — single doses of IBI3016 administered by subcutaneous injection
Primary outcomes
- Number of Participants with Adverse Events (Through 24 weeks, up to approximately 12 months)
Eligibility information
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
Study locations
- Medical Corporation Heishinkai OPHAC Hospital, Osaka, 532-003 Japan
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.