Hypertension (HTN)Phase 1NCT07529600

A Phase I Clinical Study of ART101 Injection in Healthy Adult Subjects

A Phase 1 study testing Subcutaneous (SC) single dose in people with Hypertension (HTN), run by Arnatar Therapeutics, Inc. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase I clinical study, which is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single subcutaneous injection of ART101 injection in healthy adult… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension (HTN)
What is being tested?: Subcutaneous (SC) single dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesChina
Study dates: 18 Jan 2024to 19 Dec 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Beijing Friendship Hospital, Capital Medical University
Beijing
Suzhou Arnatar Therapeutics Co., Ltd
Suzhou, Jiangsu

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART101 Injection in Healthy Adult Subjects

This study is planned to include 5 dose groups, with an estimated maximum sample size of approximately 40 subjects. To reduce the safety risk to subjects, a sentinel method will be used in Dose Group 1, where 2 subjects (1 receiving the investigational drug and 1 receiving placebo) will be enrolled first, followed by 6 subjects (5 receiving the investigational drug and 1 receiving placebo). There will be at least a 7-day interval between the administration to the sentinel subjects and the other subjects in Dose Group 1. Subjects in each dose group will receive a single subcutaneous injection of ART101 injection or placebo on Day 1 after at least 8 hours of fasting.

Group 1 Single subcutaneous injection 25 mg (N=6) Placebo (N=2) Group 2 Single subcutaneous injection 75 mg (N=6) Placebo (N=2) Group 3 Single subcutaneous injection 150 mg (N=6) Placebo (N=2) Group 4 Single subcutaneous injection 300 mg (N=6) Placebo (N=2) Group 5 (Optional) Single subcutaneous injection ≤600 mg (N=6) Placebo (N=2) The study procedures include a screening period, a treatment period, a follow-up period, and an early termination/study completion follow-up.

Read the detailed description

The clinical trial was conducted by the Suzhou branch of Suzhou Arnatar Therapeutics Co., Ltd in China.

Conditions: Hypertension (HTN)
Being tested: Subcutaneous (SC) single dose
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subcutaneous (SC) single doseDrug
all administered via subcutaneous injection.

Study groups in NCT07529600
Study group	Role	What they receive
25mg	Other	Subjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo Receives: Drug: Subcutaneous (SC) single dose
75mg	Other	Subjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo Receives: Drug: Subcutaneous (SC) single dose
150mg	Other	Subjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo Receives: Drug: Subcutaneous (SC) single dose
300 mg	Other	Subjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo Receives: Drug: Subcutaneous (SC) single dose
600 mg	Other	Subjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo Receives: Drug: Subcutaneous (SC) single dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess safety of ART101 by the incidence of adverse events, adverse events of special interest and SAEs
Measured: 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.
Measured: Up to Day 169 post first dose administration

Secondary outcomes (9)

Serum PK Parameters: Maximum Concentration (Cmax)
Measured: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Concentration change in pharmacodynamics of ART101 by noting change from baseline of serum angiotensinogen.
Measured: Day -2 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.
Urine PK Parameters:Renal Clearance (Ae)
Measured: Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.
Serum PK Parameters: Time for maximum concentration (Tmax)
Measured: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Serum PK Parameters: Area under the curve (AUC)
Measured: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Serum PK Parameters- Elimination half-life (t½)
Measured: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Serum PK parameters: Volume of distribution (Vz/F)
Measured: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Urine PK parameters: Fraction of drug excreted in urine (fe)
Measured: Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.
Urine PK parameters: Renal Clearance (CLr)
Measured: Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 202419 Dec 2025

First posted14 Apr 2026
Study start18 Jan 2024
Primary completion19 Dec 2025
Study completion19 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07529600
Sponsor's protocol ID: ART101-CN-01
Status last verified: Mar 2026
First submitted: 22 Mar 2026
Last updated: 14 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART101 Injection in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT07529600
Acronym / sponsor ID: ART101-CN-01
Conditions: Hypertension (HTN)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Arnatar Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 18 Jan 2024 (actual)
Primary completion: 19 Dec 2025 (actual)
Study completion: 19 Dec 2025 (actual)
First posted: 14 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The clinical trial was conducted by the Suzhou branch of Suzhou Arnatar Therapeutics Co., Ltd in China.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
25mg	Other	Drug: Subcutaneous (SC) single doseSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
75mg	Other	Drug: Subcutaneous (SC) single doseSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
150mg	Other	Drug: Subcutaneous (SC) single doseSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
300 mg	Other	Drug: Subcutaneous (SC) single doseSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo
600 mg	Other	Drug: Subcutaneous (SC) single doseSubjects will be randomized in a 6:2 ratio to receive either the investigational drug or placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Subcutaneous (SC) single doseall administered via subcutaneous injection.	Drug	150mg, 25mg, 300 mg, 600 mg, 75mg

Primary outcome

Assess safety of ART101 by the incidence of adverse events, adverse events of special interest and SAEs
Time frame: Up to Day 169 post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: Up to Day 169 post first dose administration
Fasting serum chemistry, fasting hematology, fasting coagulation, fasting LFTs, fasting lipid panel, fasting glycemic assessment, urinalysis will be assessed.

9 secondary outcomes

Serum PK Parameters: Maximum Concentration (Cmax)
Time frame: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Concentration change in pharmacodynamics of ART101 by noting change from baseline of serum angiotensinogen.
Time frame: Day -2 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.
Urine PK Parameters:Renal Clearance (Ae)
Time frame: Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.
Serum PK Parameters: Time for maximum concentration (Tmax)
Time frame: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Serum PK Parameters: Area under the curve (AUC)
Time frame: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Serum PK Parameters- Elimination half-life (t½)
Time frame: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Serum PK parameters: Volume of distribution (Vz/F)
Time frame: Samples will be collected at 11 timepoints ，including 1 timepoint pre-dose on day 1, 8 timepoints post dosing on day 1,1 timepoint on day 2 and 1 timepoint Day 3 post dosing.
Urine PK parameters: Fraction of drug excreted in urine (fe)
Time frame: Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.
Urine PK parameters: Renal Clearance (CLr)
Time frame: Urine will be collected between 1 hour to 0 hour pre dosing, 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours post dosing.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruihua Dong principal investigator

Beijing Friendship Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Subcutaneous (SC) single dose in people with Hypertension (HTN), run by Arnatar Therapeutics, Inc. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess safety of ART101 by the incidence of adverse events, adverse events of special interest and SAEs (time frame: Up to Day 169 post first dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07529600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.