HypertensionPhase 1NCT07556796
Study of IBI3016 in People With Mild or Moderate Hypertension Patients
A Phase 1 study testing IBI3016 in people with Hypertension, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- IBI3016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 16 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- IBI3016, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3016Drug
Solution of Injection
PlaceboOther
0.9% sodium chloride saline solution
| Study group | Role | What they receive |
|---|---|---|
| IBI3016 dose 4 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| IBI3016 dose 3 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| IBI3016 dose 2 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| IBI3016 dose 1 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| placebo | Placebo comparator | subcutaneous injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety indicators-Number of Participants with Adverse Events (AEs)
up to approximately 12 months
Measured: from baseline to week 12
Secondary outcomes (11)
Plasma pharmacokinetic parameters-peak concentration（Cmax）
Measured: from baseline to week 12
Urinary pharmacokinetic parameters-drug amount excreted(Ae)
Measured: 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
Measured: from baseline to week 12
Plasma pharmacokinetic parameters-Time to peak concentration（Tmax）
Measured: from baseline to week 12
Plasma pharmacokinetic parameters-AUC（0-last）
Measured: from baseline to week 12
Plasma pharmacokinetic parameters- AUC（0-inf）
Measured: from baseline to week 12
Plasma pharmacokinetic parameters- half-life
Measured: from baseline to week 12
Urinary pharmacokinetic parameters-Fraction Excreted(Fe)
Measured: from baseline to week 12
Urinary pharmacokinetic parameters-Renal Clearance rate (CLr)
Measured: 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)
Measured: 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)
Measured: from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start8 May 2026
- Primary completion16 Oct 2027 (estimated)
- Study completion16 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556796
- Sponsor's protocol ID
- CIBI3016A102
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07556796
- Acronym / sponsor ID
- CIBI3016A102
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 16 Oct 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBI3016 dose 4 | Experimental | Drug: IBI3016subcutaneous injection |
| IBI3016 dose 3 | Experimental | Drug: IBI3016subcutaneous injection |
| IBI3016 dose 2 | Experimental | Drug: IBI3016subcutaneous injection |
| IBI3016 dose 1 | Experimental | Drug: IBI3016subcutaneous injection |
| placebo | Placebo comparator | Other: Placebosubcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- Known history of secondary hypertension.
- Orthostatic hypotension.
- Laboratory parameter assessments outside of range at screening：
- Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- Current or history of intolerance to ACEi and/or ARBs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3016Solution of Injection | Drug | IBI3016 dose 1, IBI3016 dose 2, IBI3016 dose 3, IBI3016 dose 4 |
| Placebo0.9% sodium chloride saline solution | Other | placebo |
Primary outcome
Safety indicators-Number of Participants with Adverse Events (AEs)
Time frame: from baseline to week 12
up to approximately 12 months
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3016 in people with Hypertension, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety indicators-Number of Participants with Adverse Events (AEs) (time frame: from baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.