A Phase Ⅰ b Clinical Study of ART101 Injection

NCT07614308 | Active Not Recruiting Phase 1

• 1 other identifier: ART101-CN-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single dose Phase Ib clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of a single subcutaneous injection of ART101 in patients with hypertension. The study plans to include 2 dose groups: ART101 600 mg and 800 mg. It is planned to enroll 8 subjects per group, for a total of 16 subjects. For dose escalation, a Safety Review Committee (SRC) will be established. If a dose group meets the dose escalation termination criteria, or if significant safety events occur during the dose escalation observation period (within 30 days), the SRC will discuss with the sponsor to decide whether to continue the dose escalation. The screening period for this study is ≤6 weeks. After fasting for at least 8 hours, subjects will receive a single subcutaneous injection of ART101 on Day 1 (D1). The treatment observation period is 24 weeks. At the end of the 24-week treatment observation period, if the subject's angiotensinogen level has not recovered to more than 50% of the baseline level, the follow-up period will be extended. Subjects will continue to receive visits every 12 weeks until the angiotensinogen level recovers to more than 50% of the baseline level, or until 48 weeks after administration of the investigational drug, whichever occurs first.

Conditions

Hypertension (HTN)

Outcome Measures

Primary Outcomes (2)

• Assess safety of ART101 by the incidence of adverse events, adverse events of special interest and SAEs

  Up to Day 169 post first dose administration

• Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

  Fasting serum chemistry, fasting hematology, fasting coagulation, fasting LFTs, fasting lipid panel, fasting glycemic assessment, urinalysis will be assessed.

  Up to Day 169 post first dose administration

Secondary Outcomes (9)

• Change in Systolic Blood Pressure （SBP） and Diastolic Blood Pressure（DBP ） measured by 24-hour ambulatory blood pressure monitoring (ABPM) from baseline after single-dose administration;

  1 time during Screening Period pre dosing , day 22，day 29, Day 43, day 85 and Day 169 post dosing.

• Change in Systolic Blood Pressure （SBP） and Diastolic Blood Pressure（DBP ）measured by electronic sphygmomanometer from baseline after single-dose administration;

  Day -1 pre dosing, day 1, day 2, day 3,day 8, day 15, day 22, day 29, day 43, day 57, day 85, day 127, day 169.

• serum PK Parameters:Maximum Concentration (Cmax)

  Samples will be collected at 9 timepoints on day 1 including 1 timepoint pre dosing, 1 timepoints on day 2 and 1 timepoint on day 3 post dosing.

• Concentration change in pharmacodynamics of ART101 by noting change from baseline of serum angiotensinogen.

  Day -1 pre dosing, day 1, day 3, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 (~3 Months), Day 127, Day 169 (6 Months), post first dose administration.

• PK Parameters: Time for maximum concentration (Tmax)

  Samples will be collected at 9 timepoints on day 1 including 1 timepoint pre dosing, 1 timepoints on day 2 and 1 timepoint on day 3 post dosing

Study Arms (2)

600mg

EXPERIMENTAL

8 subjects in this cohort will receive the investigational drug ART101 with a dose of 600 mg.

Drug: ART101 injection

800mg

EXPERIMENTAL

8 subjects in this cohort will receive the investigational drug ART101 with a dose of 800 mg.

Drug: ART101 injection

Interventions

ART101 injection DRUG

All participants will receive single subcutaneously of ART101 injection on day 1 .

600mg; 800mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF), male or female.
• Patients diagnosed with essential hypertension.
• Previously untreated for hypertension, or previously treated with ≤2 types of antihypertensive medications and have undergone at least a 2-week washout period prior to Visit 2 (for long-acting antihypertensive drugs, a 4-week washout period is required, e.g., chlorthalidone, amlodipine, etc.), and meet the following blood pressure measurement criteria:
• ① During the screening period and at baseline, seated systolic blood pressure (SBP) measured by OBPM is ≥140 mmHg and \<160 mmHg;
• ② During the screening period, without the use of antihypertensive medications, 24-hour ABPM shows mean SBP ≥130 mmHg and \<160 mmHg.
• Male subjects with body weight ≥50.0 kg, female subjects with body weight ≥45.0 kg, and Body Mass Index (BMI) between 18.0 and 35.0 kg/m² (inclusive).
• Maintained a normal diet and salt intake for at least 4 weeks prior to the administration of the investigational product, and has no plans to significantly change diet or body weight during the study.
• Subjects of childbearing potential, or male subjects with partners of childbearing potential, must agree to use effective contraception from the signing of the ICF until 24 weeks after the administration of the investigational product, and must refrain from donating sperm or eggs.
• Voluntarily signed a written informed consent form, understands the study procedures and content, is able to communicate effectively with the investigator, and is willing to comply with study-related regulations.

You may not qualify if:

• \. Secondary hypertension, including but not limited to renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, or drug-induced hypertension.
• \. During the screening period and at baseline, seated diastolic blood pressure (DBP) measured by OBPM is ≥120 mmHg or \<75 mmHg.
• \. History or current presence of hypotension, orthostatic hypotension, or postural orthostatic tachycardia syndrome (POTS).
• \. Occurrence of cardiovascular or cerebrovascular events within 6 months prior to screening, including but not limited to stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), or hospitalization due to heart failure.
• \. Presence of congestive heart failure (New York Heart Association \[NYHA\] functional class III-IV), or clinically significant valvular heart disease or arrhythmia (e.g., persistent atrial fibrillation) as determined by the investigator.
• \. Diagnosis of congenital long QT syndrome, family history of congenital long QT syndrome, or presence of an implanted pacemaker or automatic implantable cardioverter-defibrillator (AICD).
• \. Presence of clinically significant electrocardiogram (ECG) abnormalities as judged by the investigator at screening.
• \. Comorbid type 1 diabetes at screening, or poorly controlled type 2 diabetes (Glycated Hemoglobin \[HbA1c\] \>9.0%).
• \. Comorbid chronic liver disease, including but not limited to liver fibrosis and cirrhosis.
• \. Diagnosis of malignancy, or a history of malignancy within 5 years prior to signing the ICF (except for cured non-melanoma skin cancer and cervical intraepithelial neoplasia with no signs of recurrence).
• \. Accompanied by other severe, progressive, or uncontrolled diseases, including but not limited to diseases of the endocrine, hematological, urinary, hepatobiliary, respiratory, neurological, cardiovascular, gastrointestinal systems, or infectious diseases, wherein the investigator assesses that participation in the study would increase the risk to the subject.
• \. Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or Human Immunodeficiency Virus antibody (HIV-Ab) at screening.
• \. Laboratory abnormalities during the screening period as follows:
• Platelet count \<100×10⁹/L;
• Hemoglobin \<90 g/L;

Sponsors & Collaborators

• Arnatar Therapeutics, Inc.: lead

Study Sites (1)

Suzhou Arnatar Therapeutics Co., Ltd

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ruihua Dong

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: May 29, 2026
• Study Start: October 27, 2025
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)