Healthy VolunteersPhase 1NCT07658638
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TESP-0401 in Healthy Participants
A Phase 1 study testing TESP-0401 in people with Healthy Volunteers, run by Tes Pharma S.r.l. at 1 site in Australia.
Trial summary
The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TESP-0401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jul 2026to 3 Mar 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are healthy as determined with no clinically significant findings by the PI/delegate in medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG.
- Systolic blood pressure (SBP) ≥105 mmHg at screening measured after at least 10 minutes of rest in the supine position, and SBP ≥100 mmHg on the dosing day prior to administration of study intervention measured after at least 1 hour of rest in the supine position.
- Resting heart rate ≥50 bpm at screening and on the dosing day prior to administration of study intervention, measured after at least 10 minutes of rest in the supine position.
- BMI within the range 18 to 32 kg/m2
- Male participants who refrain from donating sperms and either remain abstinent from sexual intercourse or agree to use protocol-required contraception.
- Female participants who are not pregnant or breastfeeding and are of non-childbearing potential, or if of childbearing potential, agree to use protocol-required contraception and not to donate ova.
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- Participants able to provide signed informed consent form.
- Agree to abstain from smoking cigarettes or equivalent nicotine-containing products from 7 days prior to study drug administration through to the end of study visit.
- Willing and able to adhere to study restrictions and to be confined at the CRU.
Who cannot join
- History or presence of cardiovascular, respiratory including resolved childhood asthma, hepatic, renal, gastrointestinal including cholecystectomy, endocrinological, haematological, immunological, psychiatric including history of depression/anxiety or neurological disorders including migraine capable of (as judged by the PI/delegate) significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- History of clinically significant hypersensitivity or allergic reactions (e.g. anaphylaxis, angioedema, or severe cutaneous reactions) to any drug or excipient, including components of the study intervention, or a history of multiple drug allergies, which in the opinion of the investigator would place the participant at increased risk or contraindicate participation in the study.
- Abnormal blood pressure determined clinically significant by the PI/delegate.
- Symptomatic herpes zoster within 3 months prior to screening.
- Evidence of active or latent tuberculosis (TB) as documented by medical history, and TB testing consisting of a positive (not indeterminate) TB test such as QuantiFERON-R TB Gold Plus test.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
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- Breast cancer within the past 10 years.
- QTc > 450 msec for male participants or > 470 msec for female participants.
- eGFR (CKD-EPI method) <80 mL/min/1.73 m2
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 x upper limit of normal (ULN).
- Total bilirubin > 1.5 x ULN
- Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, steatotic liver disease,autoimmune hepatitis, haemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the PI/delegate.
- Presence of hepatitis B surface antigen (HBsAg) at screening.
- Positive hepatitis C antibody test result at screening unless hepatitis C virus ribonucleic acid (HCV-RNA) negative test is documented.
- Individuals with Gilbert syndrome.
- Past or intended use of over-the-counter or prescription medication, including herbal medications, within 30 days or 5 half-lives (whichever is longer) prior to dosing or during the study.
- Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
- Participant who has donated blood (or blood products) or experienced a significant blood loss in excess of 450 mL within 30 days prior to screening, or who plans to donate blood during the study period.
- Receiving or has received any investigational drug (small molecule) or is currently using an investigational device, within 14 days prior to study Day 1, or within 5 elimination half-lives prior to study Day 1 (whichever is longer).
- Use of any investigational biologic (eg, monoclonal antibody) ≤ 6 months prior to study Day 1.
- Positive drug/alcohol screen at Screening or Day -1.
- Positive cotinine test at admission to the CRU on Day -1.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 10 units for males or > 10 units for females.
- History of consuming 5 or more cigarettes or equivalent nicotine-containing products per week within the last 6 months.
- Known history of drug or alcohol abuse within 1 year of Screening.
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Any other medical condition or social circumstance, which in the opinion of the PI/delegate would impede compliance with or hinder completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Novatrials
Charlestown, Suite 301, 99 Pacific Highway,NSW, 2290
Jennifer Martin, +6140961159, jennifer@novatrials.com.au
About this study
Official title: A Phase 1 Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose (Part A) and Multiple Ascending Dose (Part B) Study to Assess the Safety, Tolerability and Pharmacokinetics of IV Infusion of TESP-0401 in Healthy Participants
The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. What are the safety, tolerability, and pharmacokinetic characteristics of a single dose of TESP-0401 in healthy participants? 2. What are the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TESP-0401 in healthy participants? This study will be a randomized, placebo controlled study.
- Conditions
- Healthy Volunteers
- Being tested
- TESP-0401, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TESP-0401Drug
IV infusion, single administration, over 60 minutes, in a fasted state
PlaceboDrug
IV infusion of placebo, once, over 60 minutes, in a fasted state
TESP-0401Drug
IV infusion, QD for 7 days, over 60 minutes, in a fasted state
PlaceboDrug
IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state
| Study group | Role | What they receive |
|---|---|---|
| Part A SAD - Cohort 1 | Experimental | IV, once, over 60 minutes, in a fasted state Receives: Drug: TESP-0401 |
| Part A SAD - Placebo Cohort 1 | Placebo comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part A SAD - Cohort 2 | Experimental | IV, once, over 60 minutes, in a fasted state Receives: Drug: TESP-0401 |
| Part A SAD - Placebo Cohort 2 | Placebo comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part A SAD - Cohort 3 | Experimental | IV, once, over 60 minutes, in a fasted state Receives: Drug: TESP-0401 |
| Part A SAD - Placebo Cohort 3 | Placebo comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part A SAD - Cohort 4 | Experimental | IV, once, over 60 minutes, in a fasted state Receives: Drug: TESP-0401 |
| Part A SAD - Placebo Cohort 4 | Placebo comparator | IV infusion of placebo, once, over 60 minutes, in afasted state Receives: Drug: Placebo |
| Part A SAD - Cohort 5 | Experimental | IV, once, over 60 minutes, in a fasted state Receives: Drug: TESP-0401 |
| Part A SAD - Placebo Cohort 5 | Placebo comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part A SAD - Cohort 6 | Experimental | IV, once, over 60 minutes in a fasted state Receives: Drug: TESP-0401 |
| Part A SAD - Placebo Cohort 6 | Placebo comparator | IV infusion of placebo, once, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part B MAD - Cohort 1 | Experimental | IV infusion,QD for 7 days, over 60 minutes, ina fasted state Receives: Drug: TESP-0401 |
| Part B MAD - Placebo Cohort 1 | Placebo comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part B MAD - Cohort 2 | Experimental | IV infusion, QD for 7 days, over 60 minutes,in a fasted state Receives: Drug: TESP-0401 |
| Part B MAD - Placebo Cohort 2 | Placebo comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part B MAD - Cohort 3 | Experimental | IV infusion, QD for 7 days, over 60 minutes,in a fasted state Receives: Drug: TESP-0401 |
| Part B MAD - Placebo Cohort 3 | Placebo comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state Receives: Drug: Placebo |
| Part B MAD - Cohort 4 | Experimental | IV infusion, QD for 7 days, over 60 minutes,in a fasted state Receives: Drug: TESP-0401 |
| Part B MAD - Placebo Cohort 4 | Placebo comparator | IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with SAEs, TEAEs, with abnormal clinical laboratory tests results, abnormal vital signs, abnormal ECG readings and abnormal physical examination findings
Measured: up to 8 days after the last dose
Secondary outcomes (7)
Maximum concentration of the drug (Cmax) following single and multiple doses of TESP-0401 in healthy participants
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Time to peak concentration (Tmax) following single and multiple doses of TESP-0401 in healthy participants
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Clearance (CL) following single and multiple doses of TESP-0401 in healthy participants
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Elimination half-life (t1/2) following single and multiple doses of TESP-0401 in healthy participants
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Volume of distribution (Vd) following single and multiple doses of TESP-0401 in healthy participants.
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Area under the curve (AUC) - AUC0-24h, AUC0-last, AUC0-inf following single and multiple doses of TESP-0401 in healthy participants.
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Accumulation ratio (AR) following single and multiple doses of TESP-0401 in healthy participants.
Will be conducted using a non-compartmental approach.
Measured: up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start8 Jul 2026
- Primary completion3 Mar 2027 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tes Pharma S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tes Pharma AU Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658638
- Sponsor's protocol ID
- TESP-0401-001
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose (Part A) and Multiple Ascending Dose (Part B) Study to Assess the Safety, Tolerability and Pharmacokinetics of IV Infusion of TESP-0401 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07658638
- Acronym / sponsor ID
- TESP-0401-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tes Pharma S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Tes Pharma AU Pty Ltd
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 22 Jun 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.
The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. What are the safety, tolerability, and pharmacokinetic characteristics of a single dose of TESP-0401 in healthy participants? 2. What are the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TESP-0401 in healthy participants? This study will be a randomized, placebo controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Part A SAD - Cohort 1 | Experimental | Drug: TESP-0401IV, once, over 60 minutes, in a fasted state |
| Part A SAD - Placebo Cohort 1 | Placebo comparator | Drug: PlaceboIV infusion of placebo, once, over 60 minutes, in a fasted state |
| Part A SAD - Cohort 2 | Experimental | Drug: TESP-0401IV, once, over 60 minutes, in a fasted state |
| Part A SAD - Placebo Cohort 2 | Placebo comparator | Drug: PlaceboIV infusion of placebo, once, over 60 minutes, in a fasted state |
| Part A SAD - Cohort 3 | Experimental | Drug: TESP-0401IV, once, over 60 minutes, in a fasted state |
| Part A SAD - Placebo Cohort 3 | Placebo comparator | Drug: PlaceboIV infusion of placebo, once, over 60 minutes, in a fasted state |
| Part A SAD - Cohort 4 | Experimental | Drug: TESP-0401IV, once, over 60 minutes, in a fasted state |
| Part A SAD - Placebo Cohort 4 | Placebo comparator | Drug: PlaceboIV infusion of placebo, once, over 60 minutes, in afasted state |
| Part A SAD - Cohort 5 | Experimental | Drug: TESP-0401IV, once, over 60 minutes, in a fasted state |
| Part A SAD - Placebo Cohort 5 | Placebo comparator | Drug: PlaceboIV infusion of placebo, once, over 60 minutes, in a fasted state |
| Part A SAD - Cohort 6 | Experimental | Drug: TESP-0401IV, once, over 60 minutes in a fasted state |
| Part A SAD - Placebo Cohort 6 | Placebo comparator | Drug: PlaceboIV infusion of placebo, once, over 60 minutes, in a fasted state |
| Part B MAD - Cohort 1 | Experimental | Drug: TESP-0401IV infusion,QD for 7 days, over 60 minutes, ina fasted state |
| Part B MAD - Placebo Cohort 1 | Placebo comparator | Drug: PlaceboIV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
| Part B MAD - Cohort 2 | Experimental | Drug: TESP-0401IV infusion, QD for 7 days, over 60 minutes,in a fasted state |
| Part B MAD - Placebo Cohort 2 | Placebo comparator | Drug: PlaceboIV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
| Part B MAD - Cohort 3 | Experimental | Drug: TESP-0401IV infusion, QD for 7 days, over 60 minutes,in a fasted state |
| Part B MAD - Placebo Cohort 3 | Placebo comparator | Drug: PlaceboIV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
| Part B MAD - Cohort 4 | Experimental | Drug: TESP-0401IV infusion, QD for 7 days, over 60 minutes,in a fasted state |
| Part B MAD - Placebo Cohort 4 | Placebo comparator | Drug: PlaceboIV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants who are healthy as determined with no clinically significant findings by the PI/delegate in medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG.
- Systolic blood pressure (SBP) ≥105 mmHg at screening measured after at least 10 minutes of rest in the supine position, and SBP ≥100 mmHg on the dosing day prior to administration of study intervention measured after at least 1 hour of rest in the supine position.
- Resting heart rate ≥50 bpm at screening and on the dosing day prior to administration of study intervention, measured after at least 10 minutes of rest in the supine position.
- BMI within the range 18 to 32 kg/m2
- Male participants who refrain from donating sperms and either remain abstinent from sexual intercourse or agree to use protocol-required contraception.
Key exclusion criteria (28 listed)
- History or presence of cardiovascular, respiratory including resolved childhood asthma, hepatic, renal, gastrointestinal including cholecystectomy, endocrinological, haematological, immunological, psychiatric including history of depression/anxiety or neurological disorders including migraine capable of (as judged by the PI/delegate) significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- History of clinically significant hypersensitivity or allergic reactions (e.g. anaphylaxis, angioedema, or severe cutaneous reactions) to any drug or excipient, including components of the study intervention, or a history of multiple drug allergies, which in the opinion of the investigator would place the participant at increased risk or contraindicate participation in the study.
- Abnormal blood pressure determined clinically significant by the PI/delegate.
- Symptomatic herpes zoster within 3 months prior to screening.
- Evidence of active or latent tuberculosis (TB) as documented by medical history, and TB testing consisting of a positive (not indeterminate) TB test such as QuantiFERON-R TB Gold Plus test.
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 |
|---|---|---|
| TESP-0401IV infusion, single administration, over 60 minutes, in a fasted state | Drug | Part A SAD - Cohort 1, Part A SAD - Cohort 2, Part A SAD - Cohort 3, Part A SAD - Cohort 4, Part A SAD - Cohort 5, Part A SAD - Cohort 6 |
| PlaceboIV infusion of placebo, once, over 60 minutes, in a fasted state | Drug | Part A SAD - Placebo Cohort 1, Part A SAD - Placebo Cohort 2, Part A SAD - Placebo Cohort 3, Part A SAD - Placebo Cohort 4, Part A SAD - Placebo Cohort 5, Part A SAD - Placebo Cohort 6 |
| TESP-0401IV infusion, QD for 7 days, over 60 minutes, in a fasted state | Drug | Part B MAD - Cohort 1, Part B MAD - Cohort 2, Part B MAD - Cohort 3, Part B MAD - Cohort 4 |
| PlaceboIV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state | Drug | Part B MAD - Placebo Cohort 1, Part B MAD - Placebo Cohort 2, Part B MAD - Placebo Cohort 3, Part B MAD - Placebo Cohort 4 |
Primary outcome
Number of participants with SAEs, TEAEs, with abnormal clinical laboratory tests results, abnormal vital signs, abnormal ECG readings and abnormal physical examination findings
Time frame: up to 8 days after the last dose
7 secondary outcomes
Maximum concentration of the drug (Cmax) following single and multiple doses of TESP-0401 in healthy participants
Time frame: up to 9 days
Time to peak concentration (Tmax) following single and multiple doses of TESP-0401 in healthy participants
Time frame: up to 9 days
Clearance (CL) following single and multiple doses of TESP-0401 in healthy participants
Time frame: up to 9 days
Elimination half-life (t1/2) following single and multiple doses of TESP-0401 in healthy participants
Time frame: up to 9 days
Volume of distribution (Vd) following single and multiple doses of TESP-0401 in healthy participants.
Time frame: up to 9 days
Area under the curve (AUC) - AUC0-24h, AUC0-last, AUC0-inf following single and multiple doses of TESP-0401 in healthy participants.
Time frame: up to 9 days
Accumulation ratio (AR) following single and multiple doses of TESP-0401 in healthy participants.
Time frame: up to 9 days
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 14 Sep 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.
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 TESP-0401 in people with Healthy Volunteers, run by Tes Pharma S.r.l. at 1 site in Australia.
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 9 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 14 Sep 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Contact Jennifer Martin (+6140961159, jennifer@novatrials.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with SAEs, TEAEs, with abnormal clinical laboratory tests results, abnormal vital signs, abnormal ECG readings and abnormal physical examination findings (time frame: up to 8 days after the last dose). 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 14 Sep 2026.