HealthyPhase 1NCT04255875
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
A Phase 1 study testing PF-07209326 in people with Healthy and Sickle Cell Anemia, run by Pfizer at 16 sites in United States.
Trial summary
This Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants with sickle cell disease. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Sickle Cell Anemia
- What is being tested?
- PF-07209326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 16 sitesUnited States
- Study dates
- 5 Feb 2020to 7 Jul 2023
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Participants between the ages of 16 and 70 years old with a confirmed diagnosis of stable sickle cell disease (HbSS or HBS β0 thalassemia).
- Medical history of ≥2 and ≤ 10 medical utilization VOCs in 12 months prior to screening.
- ≥75% of daily ePRO diary completion, over a minimum of 14 days during the screening period.
- Fully vaccinated for COVID-19 in accordance with the Center for Disease Control guidance prior to Screening or must be negative for SARS-CoV-2 by polymerase chain reaction (PCR) within 72 hours of the Day 1 visit.
- Body Mass Index (BMI) ≤34.9 kg/m2 and weight ≥50 kg.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, immunocompromised (or known disorder of the immune system), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
- Participants with any of the following acute or chronic infections or infection history:
- Any infection requiring treatment within 2 weeks prior to the screening visit.
- Any infection requiring hospitalization, parenteral antimicrobial therapy within 30 days of the first dose of investigational product.
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- Any infection judged to be an opportunistic infection, within the past 6 months of the first dose of the investigational product.
- Known active or history of frequent bacterial, viral, fungal, mycobacterial or other infections as determined by the PI.
- Participants with a fever within the last 7 days prior to dosing.
- Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Evidence of ongoing uncontrolled clinically significant co-morbidity (e.g. intercurrent events that result in signs symptoms that have an adverse impact on the respective individual's usual function) hematological (non-SCD), renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including stroke within 2 years prior to screening), hepatic, psychiatric or neurological.
- Evidence or history of cardiac disease includes myocardial infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, and ventricular tachycardia), left ventricular failure, unstable angina, and coronary artery bypass grafting.
- History of cancer (other than cutaneous basal cell or carcinoma in-situ) in the previous 5 years.
- Active infection with Hepatitis B or C or HIV. Individuals seropositive for infection with Hepatitis C must be negative for viral RNA by PCR on at least 2 determinations.
- History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
- Major surgery <3 months prior to baseline or planned significant medical procedures during the study.
- Participants with any of the following acute or chronic infections or infection history:
- Any infection requiring systemic treatment within 2 weeks prior to the screening visit.
- Any infection requiring hospitalization, parenteral antimicrobial therapy within 30 days of the first dose of investigational product.
- Any infection judged to be an opportunistic infection, within the past 6 months of the first dose of the investigational product.
- Known active or history of frequent viral, fungal or other infections as determined by the Investigator.
- Participants with a fever within the last 7 days prior to dosing.
- Evidence or history of clinically significant orthostatic blood pressure changes.
- Other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
- Administration of voxelotor within 4 weeks prior to screening or planned use during the study.
- Administration of crizanlizumab within 12 weeks prior to screening or planned use during the study.
- Planned transfusion during the study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Children's Healthcare of Atlanta - Egleston Hospital-Aflac Cancer and Blood Disorders Center
Atlanta, Georgia, 30322
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Lee Health - Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33023
Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33024
UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas, 77004
Memorial Hermann clinical research unit
Houston, Texas, 77030
UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas, 77030
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032
CUIMC Research Pharmacy
New York, New York, 10032
CUMC Research Pharmacy
New York, New York, 10032
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
Howard University College of Medicine
Washington D.C., District of Columbia, 20060
About this study
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED EVALUATION OF SINGLE DOSES OF PF-07209326 IN HEALTHY PARTICIPANTS (SAFETY, TOLERABILITY, AND PHARMACOKINETICS [PK]) FOLLOWED BY AN OPEN LABEL, REPEAT DOSE EVALUATION IN SICKLE CELL DISEASE PARTICIPANTS (SAFETY, TOLERABILITY, PK AND EFFICACY)
This Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants with sickle cell disease.
Read the detailed description
Part 1 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PF-07209326 delivered by subcutaneous injection or intravenous delivery in healthy volunteer participants. After establishing the safety and tolerability in healthy participants, Part 2 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of subcutaneously delivered multiple dose of PF-07209326 in participants with sickle cell disease.
- Conditions
- Healthy, Sickle Cell Anemia
- Being tested
- Placebo, PF-07209326
- Keywords
- Safety, Tolerability, Single ascending dose, Multiple dose, Pharmacokinetics, Phase 1, First in human, First in patient
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Participants will receive matching placebo
PF-07209326Biological
Participants will receive SC or IV single ascending doses
PF-07209326Biological
SCD participants will receive a multiple dose of subcutaneous PF-07209326
| Study group | Role | What they receive |
|---|---|---|
| Treatment Healthy Participants | Experimental | Participants will receive single ascending doses of subcutaneous (SC) or intravenous PF-07209326 Receives: Biological: PF-07209326 |
| Placebo Healthy Participants | Placebo comparator | Participants will receive matching placebo Receives: Biological: Placebo |
| Treatment for SCD | Experimental | Participants will receive a multiple dose of subcutaneous PF-07209326 Receives: Biological: PF-07209326 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Measured: Day 1 up to Day 85 (SAD) or Day 113 (MD)
Percentage of subjects with laboratory abnormalities
Percentage of subjects with laboratory abnormalities
Measured: Day 1 up to Day 85 (SAD) or Day 113 (MD)
Number of subjects with change from baseline in vital signs
blood pressure, pulse rate, temperature, respiration rate
Measured: Day 1 up to Day 85 (SAD) or Day 85 (MD)
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Measured: Day 1 up to Day 85 (SAD) or Day 85 (MD)
Percentage of subjects with injection site reactions
Percentage of subjects with injection site reactions
Measured: Day 1 up to Day 11 post (SAD) Day 1 up to Day 85 (MD)
Percentage of subjects with infusion site reactions
Percentage of subjects with infusion site reactions
Measured: Day 1 up to Day 11 post each dose (SD)
Secondary outcomes (17)
SAD: Single Dose PK /Cmax
Maximum serum concentration
Measured: Day 1 up to Day 85
SAD: Single Dose PK / DN Cmax
Dose normalized Cmax
Measured: Day 1 up to Day 85
SAD: Single Dose PK / Tmax
Time for Cmax
Measured: Day 1 up to Day 85
SAD: Single Dose PK / AUClast
Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.
Measured: Day 1 up to Day 85
SAD: Single Dose PK / DN AUClast
Dose normalized AUClast
Measured: Day 1 up to Day 85
SAD: Single Dose PK / AUCinf
Area under the serum concentration time profile from time zero to infinity.
Measured: Day 1 up to Day 85
SAD: Single Dose PK / DN AUCinf
Dose normalized AUCinf.
Measured: Day 1 up to Day 85
SAD: Single Dose PK / t½
Terminal half life
Measured: Day 1 up to Day 85
SAD: Single Dose PK / CL (IV only)
Clearance
Measured: Day 1 up to Day 85
SAD: Single Dose PK / CL/F (SC only)
Apparent clearance
Measured: Day 1 up to Day 85
SAD: Single Dose PK / Vss (IV only)
Volume of distribution at steady state
Measured: Day 1 up to Day 85
SAD: Single Dose PK / Vz/F (SC only)
Apparent volume of distribution at steady state
Measured: Day 1 up to Day 85
SAD: Single Dose PK / F (SC only)
Apparent bioavailability
Measured: Day 1 up to Day 85
MD: AUCtau
Area under the curve over the dosing interval tau (1 week) after the first and last doses
Measured: Day 1 up to Day 22
SAD:ADA and/or NAb
Frequency of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) productions
Measured: Day 1 up to Day 85
MD:ADA and/or NAb
Frequency of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) productions
Measured: Day 1 up to Day 113
Patient-reported VOC event rate and VOC day rate
Efficacy in SCD participants based on an electronic patient reported outcome.
Measured: Day 1 to 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Feb 2020
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255875
- Sponsor's protocol ID
- C4071001
- Status last verified
- May 2026
- First submitted
- 3 Feb 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED EVALUATION OF SINGLE DOSES OF PF-07209326 IN HEALTHY PARTICIPANTS (SAFETY, TOLERABILITY, AND PHARMACOKINETICS [PK]) FOLLOWED BY AN OPEN LABEL, REPEAT DOSE EVALUATION IN SICKLE CELL DISEASE PARTICIPANTS (SAFETY, TOLERABILITY, PK AND EFFICACY)
- ClinicalTrials.gov ID
- NCT04255875
- Acronym / sponsor ID
- C4071001
- Conditions
- Healthy, Sickle Cell Anemia
- Keywords
- Safety, Tolerability, Single ascending dose, Multiple dose, Pharmacokinetics, Phase 1, First in human, First in patient
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 5 Feb 2020 (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 Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants with sickle cell disease.
Detailed description
Part 1 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PF-07209326 delivered by subcutaneous injection or intravenous delivery in healthy volunteer participants. After establishing the safety and tolerability in healthy participants, Part 2 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of subcutaneously delivered multiple dose of PF-07209326 in participants with sickle cell disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Healthy Participants | Experimental | Biological: PF-07209326Participants will receive single ascending doses of subcutaneous (SC) or intravenous PF-07209326 |
| Placebo Healthy Participants | Placebo comparator | Biological: PlaceboParticipants will receive matching placebo |
| Treatment for SCD | Experimental | Biological: PF-07209326Participants will receive a multiple dose of subcutaneous PF-07209326 |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Participants between the ages of 16 and 70 years old with a confirmed diagnosis of stable sickle cell disease (HbSS or HBS β0 thalassemia).
- Medical history of ≥2 and ≤ 10 medical utilization VOCs in 12 months prior to screening.
- ≥75% of daily ePRO diary completion, over a minimum of 14 days during the screening period.
- Fully vaccinated for COVID-19 in accordance with the Center for Disease Control guidance prior to Screening or must be negative for SARS-CoV-2 by polymerase chain reaction (PCR) within 72 hours of the Day 1 visit.
Key exclusion criteria (29 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, immunocompromised (or known disorder of the immune system), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- History of active or latent tuberculosis (TB) regardless of treatment or positive QuantiFeron TB test.
- Participants with any of the following acute or chronic infections or infection history:
- Participants with a history of allergic or anaphylactic reaction to therapeutic or diagnostic protein.
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 |
|---|---|---|
| PlaceboParticipants will receive matching placebo | Biological | Placebo Healthy Participants |
| PF-07209326Participants will receive SC or IV single ascending doses | Biological | Treatment Healthy Participants |
| PF-07209326SCD participants will receive a multiple dose of subcutaneous PF-07209326 | Biological | Treatment for SCD |
Primary outcome
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Time frame: Day 1 up to Day 85 (SAD) or Day 113 (MD)
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Percentage of subjects with laboratory abnormalities
Time frame: Day 1 up to Day 85 (SAD) or Day 113 (MD)
Percentage of subjects with laboratory abnormalities
Number of subjects with change from baseline in vital signs
Time frame: Day 1 up to Day 85 (SAD) or Day 85 (MD)
blood pressure, pulse rate, temperature, respiration rate
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Time frame: Day 1 up to Day 85 (SAD) or Day 85 (MD)
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Percentage of subjects with injection site reactions
Time frame: Day 1 up to Day 11 post (SAD) Day 1 up to Day 85 (MD)
Percentage of subjects with injection site reactions
Percentage of subjects with infusion site reactions
Time frame: Day 1 up to Day 11 post each dose (SD)
Percentage of subjects with infusion site reactions
17 secondary outcomes
SAD: Single Dose PK /Cmax
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / DN Cmax
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / Tmax
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / AUClast
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / DN AUClast
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / AUCinf
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / DN AUCinf
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / t½
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / CL (IV only)
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / CL/F (SC only)
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / Vss (IV only)
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / Vz/F (SC only)
Time frame: Day 1 up to Day 85
SAD: Single Dose PK / F (SC only)
Time frame: Day 1 up to Day 85
MD: AUCtau
Time frame: Day 1 up to Day 22
SAD:ADA and/or NAb
Time frame: Day 1 up to Day 85
MD:ADA and/or NAb
Time frame: Day 1 up to Day 113
Patient-reported VOC event rate and VOC day rate
Time frame: Day 1 to 85
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 15 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07209326 in people with Healthy and Sickle Cell Anemia, run by Pfizer at 16 sites 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 6 inclusion and 29 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
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?
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs (time frame: Day 1 up to Day 85 (SAD) or Day 113 (MD)). The study lists 6 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 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.