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AzTrials

HealthyPhase 1NCT05206604

A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955

A Phase 1 study testing PF-07295324 and PF-07259955 in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the safety, (local and systemic) tolerability, and pharmacokinetics following multiple doses of topically applied, maximum feasible formulations of PF-07295324 (0.12% w/w) or PF-07259955 (2% w/w), on approximately 20% body surface area (BSA), in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07295324 and PF-07259955
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
9 Feb 2022to 12 Aug 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age and Sex:
  • Healthy (except obese) female participants of non-childbearing potential and/or male participants, at the time of screening, must be 18 to 60 years of age, inclusive, at the time of signing the informed consent document (ICD).
  • Male and female of non-child bearing potential participants, who are healthy as determined by medical evaluation including medical history, physical examination, vital assessments, 12 lead ECGs, and laboratory tests.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Weight:
  • Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICD and the protocol.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions:
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Participants who have any visible skin damage or skin condition (eg sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
  • Participants who have a history of or have active AD/eczema/urticaria.
  • Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following:
Show all 40Show fewer
  • A positive QuantiFERON TB Gold In-tube or equivalent test (QFT).
  • History of either untreated or inadequately treated latent or active TB infection, or current treatment for the same.
  • History of 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. As an exception a positive HBsAb test due to hepatitis B vaccination is permissible.
  • Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
  • A history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
  • Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.
  • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
  • Have a first-degree relative with hereditary immunodeficiency.
  • A history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV] -related lymphoproliferative disorder), history of lymphoma, leukemia, malignancies or signs and symptoms suggestive of current lymphatic disease.
  • Have undergone significant trauma or major surgery within 4 weeks of screening.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg. Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Prior/Concomitant Therapy:
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. (Refer to Section 6.8 Concomitant Therapy for additional details).
  • Participants who are vaccinated with vaccines that have live components (or live attenuated vaccines) within the 6 weeks prior to the first dose of PF-07295324/vehicle or PF-07259955/vehicle or who are expected to be vaccinated during treatment or during follow-up period.
  • NOTE regarding COVID vaccines with authorization or approval for emergency use:
  • There is no requirement for washout of COVID vaccines prior to the first dose of PF-07295324/vehicle or PF-07259955/vehicle if the vaccine is not live attenuated (eg, mRNA, utilizing a viral vector,inactivated virus).There is no protocol-specified requirement for the interruption of IP dosing prior to or after vaccination if the COVID vaccine is not live attenuated.
  • Participants in any cohort of this study can only be randomized and receive the IP in only 1 cohort of this study.
  • Prior/Concurrent Clinical Study Experience:
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  • Diagnostic Assessments:
  • A positive urine drug test.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN);
  • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
  • Other Exclusions:
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
  • Use of tobacco/nicotine containing products more than 5 cigarettes/day.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of serious adverse reactions or hypersensitivity to any topical drug; or known allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the PF-07295324 IB and PF-07259955 IB.
  • Not willing to refrain from shaving, the use of depilatories or other hair-removal activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the treatment areas for 48 hours prior to admission to the CRU and for the duration of the stay in the CRU.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, VEHICLE-CONTROLLED, FIRST-IN-HUMAN, MULTIPLE-DOSE STUDY, TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS, OF TOPICALLY ADMINISTERED PF-07295324 AND PF-07259955, IN HEALTHY ADULT PARTICIPANTS

The purpose of the study is to evaluate the safety, (local and systemic) tolerability, and pharmacokinetics following multiple doses of topically applied, maximum feasible formulations of PF-07295324 (0.12% w/w) or PF-07259955 (2% w/w), on approximately 20% body surface area (BSA), in healthy adult participants.

Conditions
Healthy
Being tested
PF-07295324, PF-07259955

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07295324Drug

    Ointment

  • PF-07259955Drug

    Cream

Study groups in NCT05206604
Study groupRoleWhat they receive
PF-07295324ExperimentalOintment
Receives: Drug: PF-07295324
PF-07259955ExperimentalCream
Receives: Drug: PF-07259955

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. Treatment-related AEs and SAEs were determined by the investigator.

    Measured: Baseline up to the end of follow up (ie, up to 44 days)

  2. Number of Participants With Laboratory Abnormalities

    Hematology parameters included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils, reticulocytes, and lymphocytes. Chemistry parameters included blood urea nitrogen, creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Only those categories in which at least 1 participant had abnormal data were reported.

    Measured: At screening, admission (Day -1), on Days 5, 7, 10, at discharge (Day 12), and at early termination if applicable

  3. Number of Participants With Vital Signs Abnormalities

    Criteria for abnormality in vital signs: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine diastolic blood pressure (DBP) <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine systolic blood pressure (SBP) <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.

    Measured: At screening, on Days 1, 2, 5, 7, 10, 11, at discharge (Day 12), and at early termination if applicable

  4. Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings

    ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline (msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.

    Measured: At screening, on Days 1, 2, 5, 7, 10, 11, at discharge (Day 12), and at early termination if applicable

  5. Skin Irritation Assessments Using Draize Scoring

    Application site toleration was assessed by Draize scoring. Draize scores were defined as: 0 = No reaction visible, 1 = Trace reaction - barely perceptible pinkness, 2 = Mild reaction - readily visible pinkness, 3 = Moderate reaction - definite redness, 4 = Strong to severe reaction - very intense redness. Participants with at least 1 instance of Draize score >0 were listed.

    Measured: Screening up to Day 12 or early termination if applicable

Secondary outcomes (20)

  1. Maximum Observed Plasma Concentration (Cmax) of PF-07295324 on Days 1 and 10

    Cmax was defined as maximum plasma concentration. It was observed directly from data.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07295324 on Days 1 and 10

    Tmax was defined as time to reach maximum observed plasma concentration. It was observed directly from data.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  3. Area Under the Concentration-Time Profile From Time Zero to the Dosing Interval Tau (AUCtau) of PF-07295324 on Days 1 and 10

    AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts and tau = 24 hours for QD dosing cohorts.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  4. Average Plasma Concentration (Cavg) of PF-07295324 on Days 1 and 10

    Cavg was defined as average plasma concentration. It was determined by AUCtau/tau; where tau was the dosing interval and AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts and tau = 24 hours for QD dosing cohorts.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  5. Pre-Dose Concentration (Ctrough) of PF-07295324 on Days 1 and 10

    Ctrough was defined as pre-dose concentration. It was observed directly from data.

    Measured: Pre-dose on Days 1 and 10

  6. Observed Accumulation Ratio for Cmax (Rac[Cmax]) of PF-07295324 on Day 10

    Rac(Cmax) was defined as observed accumulation ratio for Cmax and was determined by Cmax on Day 10/Cmax on Day 1. Cmax was defined as maximum plasma concentration. Accumulation ratios was not calculated due to Day 1 Cmax values below the limit of quantification.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  7. Observed Accumulation Ratio for AUCtau (Rac[AUCtau]) of PF-07295324 on Day 10

    Rac(AUCtau) was defined as observed accumulation ratio for AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts and tau = 24 hours for QD dosing cohorts. Rac[AUCtau] was calculated by AUCtau on Day 10/AUCtau on Day 1 and accumulation ratios was not calculated due to Day 1 AUCtau values below the limit of quantification.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  8. Terminal Half-Life (t1/2) of PF-07295324 on Day 10

    t1/2 was defined as terminal half-life. It was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.

    Measured: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  9. Apparent Clearance (CL/F) of PF-07295324 on Day 10

    CL/F was defined as aparent clearance. It was determined by Dose/AUCtau. AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts).

    Measured: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  10. Apparent Volume of Distribution (Vz/F) of PF-07295324 on Day 10

    Vz/F was defined as apparant volume of distribution. It was determined by Dose/(AUCtau * kel). AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts). kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.

    Measured: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  11. Cmax of PF-07259955 on Days 1 and 10

    Cmax was defined as maximum plasma concentration. It was observed directly from data.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  12. Tmax of PF-07259955 on Days 1 and 10

    Tmax was defined as time to reach maximum observed plasma concentration. It was observed directly from data.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  13. AUCtau of PF-07259955 on Days 1 and 10

    AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  14. Cavg of PF-07259955 on Days 1 and 10

    Cavg was defined as average plasma concentration. It was determined by AUCtau/tau; where tau was the dosing interval and AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  15. Ctrough of PF-07259955 on Days 1 and 10

    Ctrough was defined as pre-dose concentration. It was observed directly from data.

    Measured: Pre-dose on Days 1 and 10

  16. Rac(Cmax) of PF-07259955 on Day 10

    Rac(Cmax) was defined as observed accumulation ratio for Cmax and was determined by Cmax on Day 10/Cmax on Day 1. Cmax was defined as maximum plasma concentration.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  17. Rac(AUCtau) of PF-07259955 on Day 10

    Rac(AUCtau) was defined as observed accumulation ratio for AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau, the dosing interval. tau = 12 hours for BID dosing cohorts. Accumulation ratios was not calculated due to Day 1 AUCtau values below the limit of quantification.

    Measured: On Days 1 and 10 at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  18. t½ of PF-07259955 on Day 10

    t1/2 was defined as terminal half-life. It was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.

    Measured: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  19. CL/F of PF-07259955 on Day 10

    CL/F was defined as aparent clearance. It was determined by Dose/AUCtau. AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts).

    Measured: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

  20. Vz/F of PF-07259955 on Day 10

    Vz/F was defined as apparant volume of distribution. It was determined by Dose/(AUCtau * kel). AUCtau was area under the plasma concentration-time profile from time zero to time tau, the dosing interval (12 hours for BID cohorts and 24 hours for QD cohorts). kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.

    Measured: On Days 1, 2, 5, 7, 10, 11, 12, and early termination (if applicable) at pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours after application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start9 Feb 2022
  3. Primary completion12 Aug 2022
  4. Study completion12 Aug 2022

Resources

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
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05206604
Sponsor's protocol ID
C4711001
Status last verified
Sep 2024
First submitted
12 Jan 2022
Last updated
14 Nov 2024
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07295324 and PF-07259955 in people with Healthy, run by Pfizer 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 8 inclusion and 40 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 14 Nov 2024. 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. 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?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to the end of follow up (ie, up to 44 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?

On the ClinicalTrials.gov record for NCT05206604.

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 Nov 2024.

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