Study of IBI3016 in People With Mild or Moderate Hypertension Patients

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Features of a Single Subcutaneous Administration of IBI3016 in Patients With Mild or Moderate Hypertension in China

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.

This study is a double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension. The study plans to enroll approximately 30 subjects with mild to moderate hypertension (msSBP ≥140 mmHg and ≥170 mmHg) receiving antihypertensive medication. Eligible subjects will be randomly assigned in a 1:1:1:1:1 ratio to either the IBI3016 dose 1 group, the IBI3016 dose 2 group, the IBI3016 dose 3 group, the IBI3016 dose 4 group, or the placebo group. The entire trial period includes a 6-week screening period, a 12-week safety follow-up period, and an extended follow-up period.

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