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.
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
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
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 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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Arnatar Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Dong, Principal investigator, Beijing Friendship Hospital
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