Study of IBI3016 in People With Mild or Moderate Hypertension Patients

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT07556796

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

30

Starts

2026-05-15

Expected to finish

2027-10-16

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• 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.
• Mean sitting SBP ≥140 mmHg and < 170 mmHg measured by OBPM. 5.Participants able to understand and comply with study procedures.

You may not qualify if…

• Known history of secondary hypertension.
• Orthostatic hypotension.
• 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
• Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
• Current or history of intolerance to ACEi and/or ARBs.
• 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

Where it is running

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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