Study of IBI3016 in People With Mild or Moderate Hypertension Patients

April 22, 2026 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI3016 dose 4
subcutaneous injection
Drug: IBI3016
Solution of Injection
Experimental: IBI3016 dose 1
subcutaneous injection
Drug: IBI3016
Solution of Injection
Experimental: IBI3016 dose 2
subcutaneous injection
Drug: IBI3016
Solution of Injection
Placebo Comparator: placebo
subcutaneous injection
Other: Placebo
0.9% sodium chloride saline solution
Experimental: IBI3016 dose 3
subcutaneous injection
Drug: IBI3016
Solution of Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety indicators-Number of Participants with Adverse Events (AEs)
Time Frame: from baseline to week 12
up to approximately 12 months
from baseline to week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma pharmacokinetic parameters-peak concentration（Cmax）
Time Frame: from baseline to week 12
from baseline to week 12
Urinary pharmacokinetic parameters-drug amount excreted(Ae)
Time Frame: from baseline to week 12
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
from baseline to week 12
Plasma pharmacokinetic parameters-Time to peak concentration（Tmax）
Time Frame: from baseline to week 12
from baseline to week 12
Plasma pharmacokinetic parameters-AUC（0-last）
Time Frame: from baseline to week 12
from baseline to week 12
Plasma pharmacokinetic parameters- AUC（0-inf）
Time Frame: from baseline to week 12
from baseline to week 12
Plasma pharmacokinetic parameters- half-life
Time Frame: from baseline to week 12
from baseline to week 12
Urinary pharmacokinetic parameters-Fraction Excreted(Fe)
Time Frame: from baseline to week 12
from baseline to week 12
Urinary pharmacokinetic parameters-Renal Clearance rate (CLr)
Time Frame: from baseline to week 12
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
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
from baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

October 16, 2027

Study Completion (Estimated)

October 16, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI3016A102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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