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)
Safety indicators-Number of Participants with Adverse Events (AEs) — from baseline to week 12 up to approximately 12 months
Trial sites (1)
Facility
City
Region
Status
Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing Municipality
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
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.
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