Pulmonary Arterial HypertensionPhase 1NCT04903730
Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
A Phase 1 study testing AER-901 Solution for Nebulization in people with Pulmonary Arterial Hypertension, run by Aerami Therapeutics at 1 site in Australia.
Trial summary
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- AER-901 Solution for Nebulization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteAustralia
- Study dates
- 24 May 2021to 2 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written consent.
- Body weight ≥ 50 kg, and a body mass index 18.0 to 32.0, inclusive.
- Female participants of non child bearing potential or if of child bearing potential, agrees to take effective contraceptive measures throughout the study period.
- Male participant: has undergone bilateral vasectomy or agrees to use effective contraceptive effective contraceptive measures or abstinence, and not donate sperm throughout the study until at least 3 months after the last dose of IP.
- Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7.
- Values for FEV1 and FVC of at least 80% of the predicted value.
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- Able to understand the nature of the study and any hazards of participation, and ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study.
- Able to successfully perform spirometry and use the inhalation device at Screening.
- Negative result for cotinine in the urine drug screen, at Screening and on Day -1.
Who cannot join
- Clinically significant physical findings, vital signs, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the subject.
- Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- Presence of acute or chronic illness or history of chronic illness.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary artery disease, or history of any psychotic mental illness.
- Upper or lower respiratory tract infection within 4 weeks before the first dose of treatment.
- Any medically identified respiratory disease(s) and/or condition(s), including but not limited to current asthma, chronic obstructive pulmonary disease, and diagnosed obstructive sleep apnoea syndrome.
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- Any clinically significant arrhythmia(s) at Screening ECG.
- History of surgery or medical intervention, or planned surgery or medical intervention, that could interfere with the objectives of the study or the safety of the volunteer.
- Currently taking any drug including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before the first dose and throughout the study, with the exception of acetylsalicylic acid (aspirin).
- Positive test result(s) for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) antibody, or coronavirus disease of 2019 (COVID-19).
- Suffering from post-COVID-19 syndrome or have tested positive for COVID-19 infection within 3 months prior to the first dose of treatment.
- Participation in another clinical study of a new chemical entity, new device, or a prescription medicine within 3 months before dosing.
- Regular alcohol consumption at levels which may increase risk of harm from alcohol-related disease or injury. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and for the duration of the study.
- A history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years, or a positive toxicology screening panel (urine test including qualitative identification of barbiturates, THC, amphetamines, methamphetamines, MDMA, phencyclidine, benzodiazepines, opiates and cocaine), or alcohol breath test.
- Current or previous use of tobacco, nicotine products, vaping device or e-cigarettes within the past 6 months.
- Loss of more than 400 mL blood (e.g., as a blood donor, or donor of blood products), during the 3 months before screening.
- Received any vaccination (e.g. for COVID-19 or influenza) within 6 weeks of treatment or plans to receive a vaccination during the study.
- History of Mycobacterium tuberculosis infection, or latent M. tuberculosis infection.
- Active or latent parasitic infection, have travelled to or have an intention to travel to a country with a high prevalence of parasitic infections within 3 months before or after receiving the treatment.
- Evidence of any other clinically significant infection, including bacterial or viral infections, at Screening and Day -1.
- Presence of any underlying physical and/or psychological medical condition that would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
- An employee of the study site or Sponsor who is directly involved in the study, or a family member of such a person.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Inhaled Doses of Imatinib Inhalation Solution (AER-901) in Adult Healthy Volunteers
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part:
- Part A: double-blind, placebo-controlled, single ascending dose (SAD).
- Part B: double-blind, placebo-controlled, multiple ascending dose (MAD).
- Part C (optional): open-label, single-dose, crossover. The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part D of the study.
- Part D: double-blind, placebo-controlled, 5 mg single dose (SD) followed by a twice daily (BID) 5 mg dose (total daily dose of 10 mg) of AER-901 in a propylene glycol formulation vs. placebo.
Oversight for the study will be provided by an SRC composed of the Principal Investigator (PI), the Sponsor's Medical Monitor (MM) and an independent MM. The decision to progress from Cohort A1 to Cohort A2 will be based on safety and tolerability data and not PK data from Cohort A1. However, the decision to progress from Cohort A2 to Cohort A3 will be based on review of safety and tolerability data from Cohort A2 and PK data from Cohort A1 by the SRC. A similar sequence will follow for subsequent progression decisions by the SRC for the cohorts in Part A and Part B of the study.
All parts of the study (A, B, C, and D) will include a 28-day Screening period, a Treatment period, and a Follow-up period. Parts C and D include an additional treatment period and a Washout period between the 2 treatment periods.
Throughout this Study Protocol, timings for post-dose assessments for spirometry, ECG, blood and urine samples for PK analysis are stated in relation to completion of the most recent dose of IP.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- AER-901 Solution for Nebulization, Placebo
- Keywords
- Healthy Subjects, Imatinib, AER-901, PAH, Imatinib mesylate, inhalation, inhaled, nebulization, FOX Mobile, inhaler, Gleevec
- Medical subject headings
- Pulmonary Arterial Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AER-901 Solution for NebulizationDrug
Also called AER-901
Part A: participants will be enrolled into 1 of up to 5 sequential cohorts (A1 to A5). Inhaled AER-901 doses of 5, 10, 20, 40, and 80mg are planned.
Part B: participants will be enrolled into 1 of up to 3 cohorts (B1 to B3).
Cohorts B2 and B3 will commence following Part D of the study and following SRC review of safety, tolerability, and PK data. A decision to dose with either a propylene glycol formulation or a sterile water formulation will be made by the SRC at the time of the review of the Part D data.
Part D has a three-part design (Treatment Periods 1 \& 2 separated by a Washout period) and will compare placebo to a single-dose of AER-901 (5 mg/mL QD) followed by two doses of AER-901.
Each cohort will consist of 8 participants (6 receiving AER 901 and 2 receiving placebo).
PlaceboDrug
Also called Placebo for Nebulization
0.45% sterile saline for injection delivered via the FOX MOBILE device.
| Study group | Role | What they receive |
|---|---|---|
| AER-901 Solution for Nebulization | Experimental | The inhalation formulation AER-901 for Part A and Part B (Cohort B1 only) is a sterile, yellow solution composed of imatinib mesylate and sterile water for injection. AER-901 will be supplied in 2 solution strengths (5 mg/mL and 40 mg/mL) for nebulisation.
The AER-901 inhalation formulation for Part D is a sterile yellow solution composed of imatinib mesylate, sterile water for injection and propylene glycol. AER-901 will be supplied in 2 solution strengths (5 mg/mL and 40 mg/mL) and the Pharmacy Manual will provide guidance on preparation for nebulization. Following review of the Part D safety and PK data by the SRC, the SRC will recommend which formulation and dose of AER-901 (sterile water vs propylene glycol) will be used in Parts B (Cohorts B2 and B3) and Part C.
The solution will be filled into a suitable container-closure system and delivered via a nebuliser known as the FOX® MOBILE. The water acts as the medium for nebulisation. Receives: Drug: AER-901 Solution for Nebulization |
| Placebo | Placebo comparator | A volume-matching placebo (0.45% sterile saline for injection) is to be delivered via the FOX® MOBILE device. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
TEAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC)
Measured: From randomization though study completion (up to 17 days following last treatment)
Number of Participants with Serious Adverse Events (SAEs)
SAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC)
Measured: From randomization though study completion (up to 17 days following last treatment)
Secondary outcomes (4)
Systemic exposure to imatinib (in plasma) after a single administration of AER-901 (Part A)
Plasma will be collected pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 9 h, 12 h , 24 h, 48 h, and 72 h post dose.
Measured: Pre-dose through 72 hours post dose
Systemic exposure to imatinib (in plasma) after multiple administrations of AER-901 (Part B)
Plasma will be collected at Days 1, 3, 5, and 7 at pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 9 h, 12 h (and 24 h, 48 h, 72 h, and 96 h post last dose).
Measured: Pre-dose through 96 hours post last dose
Systemic exposure to imatinib (in urine) after single administration of AER-901 (Part A)
Urine will be collected pre-dose, and post dose on Day 1, 24 h, 48 h, 72 h post dose
Measured: Pre-dose through 72 hours post dose
Systemic exposure to imatinib (in urine) after multiple administrations of AER-901 (Part B)
Urine will be collected pre-dose, and post dose on Days 1, 3, 5, 7 and 24 h, 48 h, 72 h, and 96 h post last dose
Measured: Pre-dose through 96 hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start24 May 2021
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part: * Part A: double-blind, placebo-controlled, single ascending dose (SAD). * Part B: double-blind, placebo-controlled, multiple ascending dose (MAD). * Part C (optional): open-label, single-dose, crossover. The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part D of the study. * Part D: double-blind, placebo-controlled, 5 mg single dose (SD) followed by a twice daily (BID) 5 mg dose (total daily dose of 10 mg) of AER-901 in a propylene glycol formulation vs. placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerami Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Yanez, Study director, Chief Operating Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903730
- Sponsor's protocol ID
- AER-901-01-001
- Status last verified
- Dec 2022
- First submitted
- 24 May 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Inhaled Doses of Imatinib Inhalation Solution (AER-901) in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04903730
- Acronym / sponsor ID
- AER-901-01-001
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Healthy Subjects, Imatinib, AER-901, PAH, Imatinib mesylate, inhalation, inhaled, nebulization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Aerami TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 26 May 2021 (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 randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part.
Detailed description
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part:
- Part A: double-blind, placebo-controlled, single ascending dose (SAD).
- Part B: double-blind, placebo-controlled, multiple ascending dose (MAD).
- Part C (optional): open-label, single-dose, crossover. The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part D of the study.
- Part D: double-blind, placebo-controlled, 5 mg single dose (SD) followed by a twice daily (BID) 5 mg dose (total daily dose of 10 mg) of AER-901 in a propylene glycol formulation vs. placebo.
Oversight for the study will be provided by an SRC composed of the Principal Investigator (PI), the Sponsor's Medical Monitor (MM) and an independent MM. The decision to progress from Cohort A1 to Cohort A2 will be based on safety and tolerability data and not PK data from Cohort A1. However, the decision to progress from Cohort A2 to Cohort A3 will be based on review of safety and tolerability data from Cohort A2 and PK data from Cohort A1 by the SRC. A similar sequence will follow for subsequent progression decisions by the SRC for the cohorts in Part A and Part B of the study.
All parts of the study (A, B, C, and D) will include a 28-day Screening period, a Treatment period, and a Follow-up period. Parts C and D include an additional treatment period and a Washout period between the 2 treatment periods.
Throughout this Study Protocol, timings for post-dose assessments for spirometry, ECG, blood and urine samples for PK analysis are stated in relation to completion of the most recent dose of IP.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part: * Part A: double-blind, placebo-controlled, single ascending dose (SAD). * Part B: double-blind, placebo-controlled, multiple ascending dose (MAD). * Part C (optional): open-label, single-dose, crossover. The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part D of the study. * Part D: double-blind, placebo-controlled, 5 mg single dose (SD) followed by a twice daily (BID) 5 mg dose (total daily dose of 10 mg) of AER-901 in a propylene glycol formulation vs. placebo.
| Arm | Type | Receives |
|---|---|---|
| AER-901 Solution for Nebulization | Experimental | Drug: AER-901 Solution for NebulizationThe inhalation formulation AER-901 for Part A and Part B (Cohort B1 only) is a sterile, yellow solution composed of imatinib mesylate and sterile water for injection. AER-901 will be supplied in 2 solution strengths (5 mg/mL and 40 mg/mL) for nebulisation. The AER-901 inhalation formulation for Part D is a sterile yellow solution composed of imatinib mesylate, sterile water for injection and propylene glycol. AER-901 will be supplied in 2 solution strengths (5 mg/mL and 40 mg/mL) and the Pharmacy Manual will provide guidance on preparation for nebulization. Following review of the Part D safety and PK data by the SRC, the SRC will recommend which formulation and dose of AER-901 (sterile water vs propylene glycol) will be used in Parts B (Cohorts B2 and B3) and Part C. The solution will be filled into a suitable container-closure system and delivered via a nebuliser known as the FOX® MOBILE. The water acts as the medium for nebulisation. |
| Placebo | Placebo comparator | Drug: PlaceboA volume-matching placebo (0.45% sterile saline for injection) is to be delivered via the FOX® MOBILE device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provide written consent.
- Body weight ≥ 50 kg, and a body mass index 18.0 to 32.0, inclusive.
- Female participants of non child bearing potential or if of child bearing potential, agrees to take effective contraceptive measures throughout the study period.
- Male participant: has undergone bilateral vasectomy or agrees to use effective contraceptive effective contraceptive measures or abstinence, and not donate sperm throughout the study until at least 3 months after the last dose of IP.
- Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7.
Key exclusion criteria (22 listed)
- Clinically significant physical findings, vital signs, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the subject.
- Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- Presence of acute or chronic illness or history of chronic illness.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary artery disease, or history of any psychotic mental illness.
- Upper or lower respiratory tract infection within 4 weeks before the first dose of treatment.
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 |
|---|---|---|
| AER-901 Solution for NebulizationAlso: AER-901Part A: participants will be enrolled into 1 of up to 5 sequential cohorts (A1 to A5). Inhaled AER-901 doses of 5, 10, 20, 40, and 80mg are planned. Part B: participants will be enrolled into 1 of up to 3 cohorts (B1 to B3). Cohorts B2 and B3 will commence following Part D of the study and following SRC review of safety, tolerability, and PK data. A decision to dose with either a propylene glycol formulation or a sterile water formulation will be made by the SRC at the time of the review of the Part D data. Part D has a three-part design (Treatment Periods 1 \& 2 separated by a Washout period) and will compare placebo to a single-dose of AER-901 (5 mg/mL QD) followed by two doses of AER-901. Each cohort will consist of 8 participants (6 receiving AER 901 and 2 receiving placebo). | Drug | AER-901 Solution for Nebulization |
| PlaceboAlso: Placebo for Nebulization0.45% sterile saline for injection delivered via the FOX MOBILE device. | Drug | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From randomization though study completion (up to 17 days following last treatment)
TEAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC)
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From randomization though study completion (up to 17 days following last treatment)
SAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC)
4 secondary outcomes
Systemic exposure to imatinib (in plasma) after a single administration of AER-901 (Part A)
Time frame: Pre-dose through 72 hours post dose
Systemic exposure to imatinib (in plasma) after multiple administrations of AER-901 (Part B)
Time frame: Pre-dose through 96 hours post last dose
Systemic exposure to imatinib (in urine) after single administration of AER-901 (Part A)
Time frame: Pre-dose through 72 hours post dose
Systemic exposure to imatinib (in urine) after multiple administrations of AER-901 (Part B)
Time frame: Pre-dose through 96 hours post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Yanez study director
Chief Operating Officer
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 AER-901 Solution for Nebulization in people with Pulmonary Arterial Hypertension, run by Aerami Therapeutics 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 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: From randomization though study completion (up to 17 days following last treatment)). 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 7 Dec 2022.