Hypertension (HTN)Phase 1NCT07614308
A Phase Ⅰ b Clinical Study of ART101 Injection
A Phase 1 study testing ART101 injection in people with Hypertension (HTN), run by Arnatar Therapeutics, Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- ART101 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2025to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
- -
Who cannot join
- 1. 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.
- 2. During the screening period and at baseline, seated diastolic blood pressure (DBP) measured by OBPM is ≥120 mmHg or <75 mmHg.
- 3. History or current presence of hypotension, orthostatic hypotension, or postural orthostatic tachycardia syndrome (POTS).
- 4. 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.
- 5. 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.
- 6. 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).
Show all 32Show fewer
- 7. Presence of clinically significant electrocardiogram (ECG) abnormalities as judged by the investigator at screening.
- 8. Comorbid type 1 diabetes at screening, or poorly controlled type 2 diabetes (Glycated Hemoglobin [HbA1c] >9.0%).
- 9. Comorbid chronic liver disease, including but not limited to liver fibrosis and cirrhosis.
- 10. 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).
- 11. 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.
- 12. 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.
- 13. Laboratory abnormalities during the screening period as follows:
- Platelet count <100×10⁹/L;
- Hemoglobin <90 g/L;
- eGFR <60 mL/min/1.73 m² (calculated by CKD-EPI 2021 equation);
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >1.5×ULN;
- Total Bilirubin (TBIL) >2×ULN (for subjects with Gilbert's syndrome, TBIL >3×ULN);
- Serum potassium >1.0×ULN. 14. Known allergy to oligonucleotides, drugs containing N-acetylgalactosamine (GalNAc), the investigational product used in this trial and its components, or drugs of the same class.
- 15. Presence of tattoos, scars, or birthmarks on the abdomen, upper arm, or thigh that may affect the assessment of injection site reactions.
- 16. Undergone major surgery within 3 months prior to the administration of the investigational product, or planning to undergo elective surgery during the study period.
- 17. Donated blood or experienced significant blood loss (≥400 mL) within 3 months prior to the administration of the investigational product (excluding menstrual bleeding in females), or received a blood transfusion within 12 months prior to the administration of the investigational product.
- 18. Received a live vaccine within 4 weeks prior to the administration of the investigational product, or planning to receive a live vaccine during the study period.
- 19. Use of any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) drugs within 12 months prior to the administration of the investigational product.
- 20. History of drug or substance abuse, or positive urine drug abuse screening during the screening period.
- 21. Smoking history of ≥5 cigarettes per day within 3 months prior to screening, or plan to smoke ≥5 cigarettes per day during the study period after signing the ICF.
- 22. Alcohol intake of ≥14 units/week within 4 weeks prior to screening (1 unit = 10 g of alcohol, ≈360 mL of beer / 150 mL of wine / 45 mL of 40% spirits), or unwillingness to comply with alcohol restriction requirements during the study period after signing the ICF (alcohol consumption <14 units/week, abstinence from alcohol for 24 hours prior to each visit), or positive alcohol breath test during screening.
- 23. Consumed caffeine-containing beverages (e.g., coffee, tea, caffeinated soda, and cola) within 2 days prior to the administration of the investigational product, or unwillingness to comply with requirements regarding caffeine beverage intake during the study period after signing the ICF (<5 cups of coffee/day).
- 24. Participation in other clinical trials within 3 months prior to the administration of the investigational product, or currently participating in other clinical trials (subjects may be enrolled in this study if they withdrew from the previous study before treatment, i.e., were not randomized or did not receive treatment).
- 25. Pregnant or lactating women. 26. Individuals whose job nature requires night shifts, early shifts, or rotating shifts, which may lead to blood pressure fluctuations or affect circadian blood pressure rhythms.
- 27. Use or planned use of other antihypertensive drugs (e.g., beta-blockers, phosphodiesterase-5 inhibitors) from the signing of the ICF until 24 weeks after receiving the investigational product, except for protocol-permitted antihypertensive treatments and the investigational product.
- 28. Any other condition judged by the investigator to make the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART101 Injection in Patients With Hypertension
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.
Read more
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.
Read the detailed description
This clinical trial is conducted in China by the branch company Suzhou Arnatar Therapeutics Co., Ltd
- Conditions
- Hypertension (HTN)
- Being tested
- ART101 injection
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART101 injectionDrug
All participants will receive single subcutaneously of ART101 injection on day 1 .
| Study group | Role | What they receive |
|---|---|---|
| 600mg | Experimental | 8 subjects in this cohort will receive the investigational drug ART101 with a dose of 600 mg. Receives: Drug: ART101 injection |
| 800mg | Experimental | 8 subjects in this cohort will receive the investigational drug ART101 with a dose of 800 mg. Receives: Drug: ART101 injection |
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)
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;
Measured: 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;
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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
PK Parameters: Area under the curve (AUC)
Measured: 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
PK Parameters- Elimination half-life (t½)
Measured: 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
PK parameters: Apparent terminal elimination rate (λz )
Measured: 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
PK parameters: Volume of distribution (Vz/F)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start27 Oct 2025
- Primary completion14 Oct 2026 (estimated)
- Study completionNov 2026 (estimated)
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
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
- NCT07614308
- Sponsor's protocol ID
- ART101-CN-02
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART101 Injection in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07614308
- Acronym / sponsor ID
- ART101-CN-02
- Conditions
- Hypertension (HTN)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Arnatar Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 May 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.
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.
Detailed description
This clinical trial is conducted in China by the branch company Suzhou Arnatar Therapeutics Co., Ltd
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 600mg | Experimental | Drug: ART101 injection8 subjects in this cohort will receive the investigational drug ART101 with a dose of 600 mg. |
| 800mg | Experimental | Drug: ART101 injection8 subjects in this cohort will receive the investigational drug ART101 with a dose of 800 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (32 listed)
- 1. 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.
- 2. During the screening period and at baseline, seated diastolic blood pressure (DBP) measured by OBPM is ≥120 mmHg or <75 mmHg.
- 3. History or current presence of hypotension, orthostatic hypotension, or postural orthostatic tachycardia syndrome (POTS).
- 4. 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.
- 5. 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.
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 |
|---|---|---|
| ART101 injectionAll participants will receive single subcutaneously of ART101 injection on day 1 . | Drug | 600mg, 800mg |
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
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;
Time frame: 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;
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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
PK Parameters: Area under the curve (AUC)
Time frame: 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
PK Parameters- Elimination half-life (t½)
Time frame: 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
PK parameters: Apparent terminal elimination rate (λz )
Time frame: 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
PK parameters: Volume of distribution (Vz/F)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hypertension (HTN)
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ART101 injection in people with Hypertension (HTN), run by Arnatar Therapeutics, Inc. at 1 site 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 10 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
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 29 May 2026.