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Not yet recruiting NCT07556796

Study of IBI3016 in People With Mild or Moderate Hypertension Patients

Phase I Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI3016, Placebo.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug IBI3016
    Solution of Injection
  • Other Placebo
    0.9% sodium chloride saline solution

Primary outcome measures

  • Safety indicators-Number of Participants with Adverse Events (AEs) [Time frame: from baseline to week 12]
Secondary outcome measures (11)
  • Plasma pharmacokinetic parameters-peak concentration（Cmax） [Time frame: from baseline to week 12]
  • Urinary pharmacokinetic parameters-drug amount excreted(Ae) [Time frame: from baseline to week 12]
  • Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by 24-hour ambulatory blood pressure monitoring [Time frame: from baseline to week 12]
  • Plasma pharmacokinetic parameters-Time to peak concentration（Tmax） [Time frame: from baseline to week 12]
  • Plasma pharmacokinetic parameters-AUC（0-last） [Time frame: from baseline to week 12]
  • Plasma pharmacokinetic parameters- AUC（0-inf） [Time frame: from baseline to week 12]
  • Plasma pharmacokinetic parameters- half-life [Time frame: from baseline to week 12]
  • Urinary pharmacokinetic parameters-Fraction Excreted(Fe) [Time frame: from baseline to week 12]
  • Urinary pharmacokinetic parameters-Renal Clearance rate (CLr) [Time frame: from baseline to week 12]
  • Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by mean sitting blood pressure (msBP) [Time frame: from baseline to week 12]
  • Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline after drug administration by home blood pressure monitoring (HBPM) [Time frame: from baseline to week 12]

Eligibility criteria

Inclusion criteria

  • 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.

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Anzhen Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07556796 · CIBI3016A102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗