Safety IssuesPhase 1NCT06847698
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
A Phase 1 study testing AVR-48 in people with Safety Issues and Tolerability, run by AyuVis Research, Inc. at 1 site in United States.
Trial summary
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Tolerability, Pharmacokinetics
- What is being tested?
- AVR-48
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Nov 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Healthy adult male or female, aged 18 to 55, inclusive, at Screening.
- Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening, and a minimum weight of at least 50.0 kg and a maximum weight of 100.0 kg at screening.
- Medically healthy with no clinically significant abnormalities in medical history, physical and neurologic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
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- If female of childbearing potential, must be consistently using an effective method of contraception from screening visit until 30 days after the last drug administration.
- If female and not of childbearing potential, must be either surgically sterile or post menopausal (i.e., more than 1 year since last menstrual period).
- A non-vasectomized, male subject must agree to use an effective method of birth control with female partners of childbearing potential during the study and to refrain from donating sperm for 90 days following dosing.
- No restrictions are required for a vasectomized male subject provided his vasectomy has been performed 4 months or more (and have official documentation) prior to Study Day 1. A subject who has been vasectomized less than 4 months prior to Study Day 1 or does not have official documentation of his vasectomy must follow the same restrictions as a non-vasectomized subject.
Who cannot join
- Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the PI or designee.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Has had surgery or any medical condition within 6 months prior to first dosing which may affect the distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
- Female subjects with a positive pregnancy test or who are lactating.
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- Positive urine drug or alcohol results at screening or first check-in.
- Positive cotinine results at screening.
- Positive result at screening for tuberculosis (i.e., positive result for QuantiFERON TB-Gold).
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Hormone replacement therapy will be allowed.
- Donation or loss of 50 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days prior to the first dosing.
- Plasma donation within 14 days prior to the first dosing.
- Participation in another clinical study within 30 days prior to the first dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
- Had a treatment with other investigational drug within 5 times the terminal elimination half-life (t1/2), if known (e.g., a marketed product) or within 30 days (if the t1/2 is unknown), whichever is longer, prior to Study Day 1 dosing.
- Evidence of Coronavirus Disease 2019 (COVID-19) infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
PPD
Austin, Texas, 78744
Study Principal Investigator, 877-362-2608
About this study
Official title: Phase 1, Double-Blinded, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of AVR-48
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
Read the detailed description
This is a Phase 1, 2-part, double-blinded, placebo-controlled, randomized SAD/MAD study.
The study will include 2 parts:
- Part A: SAD phase
- Part B: MAD phase
Part A - SAD phase Healthy adult subjects will be randomized to receive a single IV dose of either AVR-48 or placebo in each of 3 planned SAD cohorts. Each cohort will consist of 8 subjects in a 3:1 (active:placebo) ratio to have a total of 6 subjects receiving AVR-48 and 2 subjects receiving placebo. Each cohort will be comprised of 50% male and 50% female subjects.
All SAD cohorts will be dosed according to a sentinel dosing design to ensure safety. Initially, 2 subjects will be dosed; 1 subject will be dosed with AVR-48 and 1 subject with placebo. Blood samples for PK and safety clinical laboratory tests will be collected over the following 24 hours. If the site Principal Investigator (PI), in conjunction with the AyuVis sponsored Independent Medical Monitor, determines that acceptable safety is observed in the sentinel administration, the remaining subjects in the cohort will be dosed and identical safety and PK procedures will be performed; 5 subjects will be dosed with AVR-48 and 1 subject with placebo. Sentinel subjects will be dosed at least 48 hours prior to enrolling the remaining subjects of the cohort. All subjects will be followed for 48 hours post-dose.
Blood samples will be collected periodically for PK, cytokine panels, metabolite assessment, and safety labs; urine samples will be collected periodically for metabolite assessment, and routine safety assessments will be completed daily.
Escalation to the next higher dose will only proceed if none of the stopping criteria have been reached and when the safety and tolerability and available plasma PK analysis of the previous dose are acceptable to the site PI, Sponsor, and Safety Monitoring Committee (SMC). A minimum of 3 days will separate each dose escalation.
Part B - MAD phase Healthy adult subjects will be randomized to receive multiple IV doses of either AVR-48 or placebo in each of 3 planned MAD cohorts. Each cohort will consist of 8 subjects in a 3:1 (active: placebo) ratio to have a total of 6 subjects receiving AVR-48 and 2 subjects receiving placebo. A balance of male and female subjects in each cohort will be attempted, but the final ratio of subject sex will be determined by the available subjects who pass screening at the time of enrollment.
For Cohort 1 and Cohort 2, AVR-48 or matching placebo will be administered twice daily, every 12 hours, for a total of 13 doses over 7 days. For Cohort 3, AVR-48 will be administered once daily, for a total of 7 doses over 7 days. Subjects will be monitored for 48 hours after the last dose and will attend a follow-up visit 7 days after dosing completes.
Blood samples will be collected periodically for PK, cytokine panels, metabolite assessment, and safety labs; urine samples will be collected periodically for metabolite assessment, and routine safety assessments will be completed daily.
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Being tested
- AVR-48, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVR-48Drug
Investigational drug reconstituted in normal saline will be administered via IV
PlaceboDrug
Normal saline will be administered via IV
| Study group | Role | What they receive |
|---|---|---|
| Drug: AVR-48 | Experimental | AVR-48 is a small molecule with TLR4 modulating activity and macrophage modulator Receives: Drug: AVR-48 |
| Drug: Placebo | Placebo comparator | 0.9% saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience Adverse Events (AEs), Serious Adverse Events
Number of AEs, SAEs, and discontinuation due to AEs
Measured: Up to 16 days
Number of participants who experience ECG abnormalities
Number of participants with potentially clinically significant ECG readings
Measured: Up to 16 days
Number of participants who experience vital sign abnormalities
Number of participants with potentially clinically significant vital sign values
Measured: Up to 16 days
Number of participants who experience laboratory test abnormalities
Number of participants with potentially clinically significant laboratory test results
Measured: Up to 16 days
Number of participants who experience physical examination abnormalities
Number of participants with potentially significant physical examination findings
Measured: Up to 16 days
Secondary outcomes (13)
PK of AVR-48 in plasma: Area under the plasma-concentration time curve (AUC)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
Title: PK of AVR-48 in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Maximum observed concentration (Cmax)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Trough or minimum concentration (Ctrough)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Concentration at the end of the dosing interval (Ct)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Time to maximal observed concentration (tmax)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Accumulation ratio (comparing Day 5 Cmax to Day 1 Cmax)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Accumulation ratio (comparing Day 5 AUCtau to Day 1 AUC0-12)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Termination elimination half-life (t½)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Apparent total body clearance (CL/F)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
PK of AVR-48 in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Blood Samples will be collected for plasma analysis
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study startJun 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Model description
- Part A: Eight (8) subjects will participate in each of the 3 dose groups. Subjects will be randomized to receive either AVR-48 or placebo by IV (6 active, 2 placebo per group of 8). Part B: Eight (8) subjects will participate in each of the 3 dose groups. Subjects will be randomized to receive either AVR-48 or placebo by IV (6 active, 2 placebo per group of 8).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AyuVis Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Suchismita Acharya, PhD, Study director, AyuVis Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847698
- Sponsor's protocol ID
- AVR-48-01-001
- Status last verified
- Apr 2025
- First submitted
- 27 Aug 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double-Blinded, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of AVR-48
- ClinicalTrials.gov ID
- NCT06847698
- Acronym / sponsor ID
- AVR-48-01-001
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AyuVis Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 26 Feb 2025 (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 a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
Detailed description
This is a Phase 1, 2-part, double-blinded, placebo-controlled, randomized SAD/MAD study.
The study will include 2 parts:
- Part A: SAD phase
- Part B: MAD phase
Part A - SAD phase Healthy adult subjects will be randomized to receive a single IV dose of either AVR-48 or placebo in each of 3 planned SAD cohorts. Each cohort will consist of 8 subjects in a 3:1 (active:placebo) ratio to have a total of 6 subjects receiving AVR-48 and 2 subjects receiving placebo. Each cohort will be comprised of 50% male and 50% female subjects.
All SAD cohorts will be dosed according to a sentinel dosing design to ensure safety. Initially, 2 subjects will be dosed; 1 subject will be dosed with AVR-48 and 1 subject with placebo. Blood samples for PK and safety clinical laboratory tests will be collected over the following 24 hours. If the site Principal Investigator (PI), in conjunction with the AyuVis sponsored Independent Medical Monitor, determines that acceptable safety is observed in the sentinel administration, the remaining subjects in the cohort will be dosed and identical safety and PK procedures will be performed; 5 subjects will be dosed with AVR-48 and 1 subject with placebo. Sentinel subjects will be dosed at least 48 hours prior to enrolling the remaining subjects of the cohort. All subjects will be followed for 48 hours post-dose.
Blood samples will be collected periodically for PK, cytokine panels, metabolite assessment, and safety labs; urine samples will be collected periodically for metabolite assessment, and routine safety assessments will be completed daily.
Escalation to the next higher dose will only proceed if none of the stopping criteria have been reached and when the safety and tolerability and available plasma PK analysis of the previous dose are acceptable to the site PI, Sponsor, and Safety Monitoring Committee (SMC). A minimum of 3 days will separate each dose escalation.
Part B - MAD phase Healthy adult subjects will be randomized to receive multiple IV doses of either AVR-48 or placebo in each of 3 planned MAD cohorts. Each cohort will consist of 8 subjects in a 3:1 (active: placebo) ratio to have a total of 6 subjects receiving AVR-48 and 2 subjects receiving placebo. A balance of male and female subjects in each cohort will be attempted, but the final ratio of subject sex will be determined by the available subjects who pass screening at the time of enrollment.
For Cohort 1 and Cohort 2, AVR-48 or matching placebo will be administered twice daily, every 12 hours, for a total of 13 doses over 7 days. For Cohort 3, AVR-48 will be administered once daily, for a total of 7 doses over 7 days. Subjects will be monitored for 48 hours after the last dose and will attend a follow-up visit 7 days after dosing completes.
Blood samples will be collected periodically for PK, cytokine panels, metabolite assessment, and safety labs; urine samples will be collected periodically for metabolite assessment, and routine safety assessments will be completed daily.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A: Eight (8) subjects will participate in each of the 3 dose groups. Subjects will be randomized to receive either AVR-48 or placebo by IV (6 active, 2 placebo per group of 8). Part B: Eight (8) subjects will participate in each of the 3 dose groups. Subjects will be randomized to receive either AVR-48 or placebo by IV (6 active, 2 placebo per group of 8).
| Arm | Type | Receives |
|---|---|---|
| Drug: AVR-48 | Experimental | Drug: AVR-48AVR-48 is a small molecule with TLR4 modulating activity and macrophage modulator |
| Drug: Placebo | Placebo comparator | Drug: Placebo0.9% saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form (ICF).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Healthy adult male or female, aged 18 to 55, inclusive, at Screening.
- Continuous non smoker who has not used nicotine containing products (including e- vaping) for at least 3 months prior to the first dosing and throughout the study
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening, and a minimum weight of at least 50.0 kg and a maximum weight of 100.0 kg at screening.
Key exclusion criteria (17 listed)
- Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the PI or designee.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Has had surgery or any medical condition within 6 months prior to first dosing which may affect the distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
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 |
|---|---|---|
| AVR-48Investigational drug reconstituted in normal saline will be administered via IV | Drug | Drug: AVR-48 |
| PlaceboNormal saline will be administered via IV | Drug | Drug: Placebo |
Primary outcome
Number of participants who experience Adverse Events (AEs), Serious Adverse Events
Time frame: Up to 16 days
Number of AEs, SAEs, and discontinuation due to AEs
Number of participants who experience ECG abnormalities
Time frame: Up to 16 days
Number of participants with potentially clinically significant ECG readings
Number of participants who experience vital sign abnormalities
Time frame: Up to 16 days
Number of participants with potentially clinically significant vital sign values
Number of participants who experience laboratory test abnormalities
Time frame: Up to 16 days
Number of participants with potentially clinically significant laboratory test results
Number of participants who experience physical examination abnormalities
Time frame: Up to 16 days
Number of participants with potentially significant physical examination findings
13 secondary outcomes
PK of AVR-48 in plasma: Area under the plasma-concentration time curve (AUC)
Time frame: Up to 8 days
Title: PK of AVR-48 in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Maximum observed concentration (Cmax)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Trough or minimum concentration (Ctrough)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Concentration at the end of the dosing interval (Ct)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Time to maximal observed concentration (tmax)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Accumulation ratio (comparing Day 5 Cmax to Day 1 Cmax)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Accumulation ratio (comparing Day 5 AUCtau to Day 1 AUC0-12)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Termination elimination half-life (t½)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Apparent total body clearance (CL/F)
Time frame: Up to 8 days
PK of AVR-48 in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: Up to 8 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 6 Apr 2025.
- 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.
Suchismita Acharya, PhD study director
AyuVis Research, Inc.
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 AVR-48 in people with Safety Issues and Tolerability, run by AyuVis Research, Inc. at 1 site in United States.
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 17 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: opening soon, as of the sponsor's last update on 6 Apr 2025. 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 United States. 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 Study Principal Investigator (877-362-2608, sacharya@ayuvis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (time frame: Up to 16 days). The study lists 5 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 6 Apr 2025.