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Clinical Trials in China / NCT07556796
Starting soon Phase 1

Study of IBI3016 in People With Mild or Moderate Hypertension Patients

NCT07556796 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 1
Started
2026-05-15
Last updated
2026-04-29

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

IBI3016Placebo

IBI3016: Solution of Injection

Placebo: 0.9% sodium chloride saline solution

Study summary

A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent. 2. Males or females aged 18 to 75 years. 3 Diagnosed primary hypertension who have not been taking anti-hypertensive medication within 4 weeks prior to informed consent. 4.Mean sitting SBP ≥140 mmHg and \< 170 mmHg measured by OBPM. 5.Participants able to understand and comply with study procedures. Exclusion Criteria: 1. Known history of secondary hypertension. 2. Orthostatic hypotension. 3. Laboratory parameter assessments outside of range at screening: * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2× Upper Limit of Normal (ULN) * Total Bilirubin \> 1.5× ULN * International Normalized Ratio (INR) \> 2.0 * Serum Potassium \> 5 mmol/L * Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m² * QTcF \> 480 ms 4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor. 5. Current or history of intolerance to ACEi and/or ARBs. 6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening, or a previous diagnosis of decompensated heart failure or New York Heart Association (NYHA) grade III or IV heart failure. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07556796 on ClinicalTrials.gov ↗ ← All trials in China