Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07838220

A Study of IBI3016 in Japanese Participants

A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-003, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Male or female participants aged 18-75 years (inclusive) at the time of informed consent;
  • 2. Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin;
  • 3. Office mean sitting SBP≥ 140 mmHg and < 170 mmHg at screening

Exclusion criteria

  • 1. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea;
  • 2. History of orthostatic hypotension
  • 3. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor
  • 4. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening;
  • 5. Presence of serious active and uncontrolled physical conditions or medical history, which may be in a dangerous state during the use of the study drug, or interfere with the interpretation of efficacy and safety data of this study, as judged by the investigator prior to randomization

Treatment and study plan

IBI3016 Dose 4

Drug

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose 3

Drug

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose 2

Drug

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose 1

Drug

single doses of IBI3016 administered by subcutaneous injection

Placebo

Drug

single doses of IBI3016 administered by subcutaneous injection

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Through 24 weeks, up to approximately 12 months

Secondary outcomes

  1. Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016

    Time frame: Predose, early post-dose and up to 48 hours postdose

  2. Plasma PK: Area Under the Concentration Versus Time Curve (AUC) of IBI3016

    Time frame: Predose, Day 1, and up to 48 hours postdose

  3. Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessed by OBP and ABPM

    Time frame: Baseline, Month 3 and Month 6

  4. Change from baseline in serum angiotensinogen (AGT) concentration

    Time frame: Through 24 weeks, up to approximately 12 months

  5. Urine PK parameter: drug accumulation

    Time frame: Predose, Day 1, and up to 48 hours postdose

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of IBI3016 in Japanese Participants With Mild to Moderate Hypertension

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.