NCT07838220

Brief Summary

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.

Trial Health

77
On Track

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
13mo left

Started Aug 2026

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Aug 2026Nov 2027

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2027

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 13, 2026

Last Update Submit

September 17, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events

    Through 24 weeks, up to approximately 12 months

Secondary Outcomes (5)

  • Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016

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

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

    Predose, Day 1, and up to 48 hours postdose

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

    Baseline, Month 3 and Month 6

  • Change from baseline in serum angiotensinogen (AGT) concentration

    Through 24 weeks, up to approximately 12 months

  • Urine PK parameter: drug accumulation

    Predose, Day 1, and up to 48 hours postdose

Study Arms (5)

IBI3016 Dose1

EXPERIMENTAL

single doses of IBI3016 administered by subcutaneous injection

Drug: IBI3016 Dose 1

IBI3016 Dose 2

EXPERIMENTAL

single doses of IBI3016 administered by subcutaneous injection

Drug: IBI3016 Dose 2

IBI3016 Dose4

EXPERIMENTAL

single doses of IBI3016 administered by subcutaneous injection

Drug: IBI3016 Dose 4

Placebo

PLACEBO COMPARATOR

single doses of Placebo administered by subcutaneous injection

Drug: Placebo

IBI3016 Dose3

EXPERIMENTAL

single doses of IBI3016 administered by subcutaneous injection

Drug: IBI3016 Dose 3

Interventions

IBI3016 Dose 4DRUG

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose4
IBI3016 Dose 3DRUG

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose3
IBI3016 Dose 2DRUG

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose 2
IBI3016 Dose 1DRUG

single doses of IBI3016 administered by subcutaneous injection

IBI3016 Dose1
PlaceboDRUG

single doses of IBI3016 administered by subcutaneous injection

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • \. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea;
  • \. History of orthostatic hypotension
  • \. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor
  • \. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening;
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-003, Japan

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Wendy Duan

CONTACT

+86 010-87412310wenjing.duan@innoventbio.com

Congying Xia

CONTACT

congying.xia@innoventbio.com

Study Design

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

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

November 5, 2027

Last Updated

September 24, 2026

Record last verified: 2026-09

Locations

JP(1)