NCT07556796

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
17mo left

Started May 2026

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 14, 2026

Last Update Submit

April 22, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Safety indicators-Number of Participants with Adverse Events (AEs)

    up to approximately 12 months

    from baseline to week 12

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (5)

IBI3016 dose 4

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

IBI3016 dose 3

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

IBI3016 dose 2

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

IBI3016 dose 1

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

placebo

PLACEBO COMPARATOR

subcutaneous injection

Other: Placebo

Interventions

IBI3016DRUG

Solution of Injection

IBI3016 dose 1IBI3016 dose 2IBI3016 dose 3IBI3016 dose 4
PlaceboOTHER

0.9% sodium chloride saline solution

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Andy Guo

CONTACT

0512-69566088andy.guo@innoventbio.com

Jinling Fan

CONTACT

0512-69566088jinling.fan@innoventbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 29, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

October 16, 2027

Study Completion (Estimated)

October 16, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

CN(1)