New shot for high blood pressure takes first step in human testing
NCT ID NCT07529600
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a single injection of ART101 in 40 healthy adults to see if it is safe and how the body processes it. Participants received either the drug or a placebo. The goal is to gather initial safety data before testing in people with high blood pressure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ART101 injection
- What this could lead to
- If successful, this could lead to a new injectable treatment option for high blood pressure.
- What could go wrong
- This is a very early Phase 1 trial in only 40 healthy people, so it is not yet tested in patients with hypertension. The drug may prove unsafe or ineffective in later studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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40 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Aged 18 to 60 years (inclusive) at the time of signing the informed consent form (ICF), male or female. 2\. Generally good health, with no clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead ECG results at screening. 3\. 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 28.0 kg/m² (inclusive). 4\. Maintained a normal diet and salt intake for at least 4 weeks prior to the first dose, and has no plans to significantly change diet or body weight during the study. 5\. Women of Childbearing Potential (WOCBP) or male subjects with partners who are WOCBP must agree to use highly effective contraceptive measures from the signing of the ICF until 6 months after dosing \[for subjects not requiring extended follow-up (see Section 8.1.4)\] or until the end of extended follow-up (for subjects requiring and accepting extended follow-up beyond 6 months), and must refrain from donating sperm or eggs. WOCBP subjects must confirm their menstrual period. 6\. 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. Exclusion Criteria: * 1\. History or current presence of hypotension or orthostatic hypotension, or SBP \<100 mmHg and/or DBP \<60 mmHg at screening. 2\. History of severe diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, or reproductive systems, or current presence of diseases in the aforementioned systems judged by the investigator to be clinically significant. 3\. Comorbid type 1 diabetes at screening, or poorly controlled type 2 diabetes (Glycated Hemoglobin \[HbA1c\] \>8.0%). 4\. Known allergy to oligonucleotides, drugs containing GalNAc, the investigational product used in this study and its components, or drugs of the same class. 5\. Presence of tattoos, scars, or birthmarks on the abdomen, upper arm, or thigh that may affect the assessment of injection site reactions. 6\. Undergone major surgery within 3 months prior to the first dose, or undergone surgery that may significantly affect drug absorption, distribution, metabolism, or excretion, or planning to undergo elective surgery during the study period. 7\. Donated blood or experienced significant blood loss (≥400 mL) within 3 months prior to the first dose (excluding menstrual bleeding in females), or received a blood transfusion within 12 months prior to the first dose. 8\. Received a live vaccine within 4 weeks prior to the first dose, or planning to receive a live vaccine during the study period. 9\. Use of any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) drugs within 12 months prior to the first dose. 10\. Participated in or is currently participating in other clinical trials and received investigational drugs/devices or placebos within 3 months prior to the first dose. 11\. Use of any prescription drugs within 14 days prior to the first dose or within 5 half-lives of the washed-out drug (whichever is longer). 12\. Use of any over-the-counter (OTC) drugs, vitamin supplements, or herbal medicines within 7 days prior to the first dose or within 5 half-lives of the washed-out drug (whichever is longer). 13\. History of drug abuse/substance abuse within 5 years prior to the first dose, or positive urine drug screening (morphine, tetrahydrocannabinol, methamphetamine, methylenedioxymethamphetamine, ketamine) at screening. 14\. Use of any tobacco products within 3 months prior to the first dose, or unwillingness to stop using any tobacco products during the study period. 15\. Regular alcohol consumption within 3 months prior to the first dose, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), or unwillingness to abstain from alcohol during the study period, or alcohol breath test result \>0 mg/100 mL. 16\. Consumption of excessive amounts of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to the first dose, or consumption of any such beverages within 48 hours prior to dosing, or unwillingness to abstain from such beverages during the study period. 17\. 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. 18\. Estimated Glomerular Filtration Rate (eGFR) \<90 mL/min/1.73 m² (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula) at screening. 19\. WOCBP with a positive pregnancy test result at screening, women who are breastfeeding, or women planning to become pregnant during the study period. 20\. Any other condition judged by the investigator to make the subject unsuitable for participation in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, China
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Suzhou Arnatar Therapeutics Co., Ltd
Suzhou, Jiangsu, China
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