Hypertension
Conditions
Brief 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.
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
DRUGIBI3016
Solution of Injection
OTHERPlacebo
0.9% sodium chloride saline solution
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety indicators-Number of Participants with Adverse Events (AEs) | from baseline to week 12 | up to approximately 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetic parameters-peak concentration（Cmax） | from baseline to week 12 |
| Urinary pharmacokinetic parameters-drug amount excreted(Ae) | 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 | from baseline to week 12 |
| Plasma pharmacokinetic parameters-Time to peak concentration（Tmax） | from baseline to week 12 |
| Plasma pharmacokinetic parameters-AUC（0-last） | from baseline to week 12 |
| Plasma pharmacokinetic parameters- AUC（0-inf） | from baseline to week 12 |
| Plasma pharmacokinetic parameters- half-life | from baseline to week 12 |
| Urinary pharmacokinetic parameters-Fraction Excreted(Fe) | from baseline to week 12 |
| Urinary pharmacokinetic parameters-Renal Clearance rate (CLr) | 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) | 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) | from baseline to week 12 |
Countries
China
Contacts
CONTACTAndy Guo
CONTACTJinling Fan
Outcome results
None listed