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Healthy ParticipantsPhase 1NCT06177457

A Study to Understand the Effect of Multiple Ascending Doses of PF-07293893 in Healthy Adult Participants

A Phase 1 study testing PF-07293893 and Midazolam in people with Healthy Participants, run by Pfizer at 3 sites in 2 countries.

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

This study has four parts: Part A, Part B, Part C, and Part D. The purpose of Part A of this study is to learn about the: safety, tolerability, how PF-07293893 is processed by the body when multiple doses of PF-07293893 are given to healthy participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
PF-07293893 and Midazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
3 sitesin 2 countries
Study dates
20 Dec 2023to 2 Dec 2024
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Females of non-childbearing potential and males 18 to 65 years of age (except for optional Part C in which only males will be recruited), inclusive, at the time of signing the ICD who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • BMI of 20-35 kg/m2; and a total body weight >45kg (99 lb).
  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Capable of giving signed informed consent.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, ophthalmologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Part C Only: History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation defined by less than 1 bowel movement on average per 2 days or lactose intolerance.
  • 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 with the exception of moderate/strong CYP3A inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
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  • Previous administration with an investigational product (drug or vaccine) 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). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
  • Previous exposure to PF-07293893 treatment.
  • A positive urine drug test.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥ 140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, 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.
  • Renal impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73m². Since participants are 18 years to 65 years, 2021 Screat-based CKD-EPI eGFR is the recommended formula.
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer interpreted- ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
  • 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: ALT, AST, Bili ≥ 1.05 x 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.
  • CK > 2.5 x ULN.
  • 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 or nicotine-containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
  • Part B Only: History of sensitivity reaction to midazolam, or any of the formulation components.
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
  • Part D Only: Any contra-indication to Magnetic Resonance Imaging, including noncompatible metallic implants, severe claustrophobia, or the inability to remain still for the duration of the scan session.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Pfizer Clinical Research Unit - New Haven

    New Haven, Connecticut, 06511

  • Yale University/Magnetic Resonance Research Center (MRRC)

    New Haven, Connecticut, 06511

Other trials in United States

Belgium1 site

  • Pfizer Clinical Research Unit - Brussels

    Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, MULTI-PART RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-07293893 IN HEALTHY ADULT PARTICIPANTS

This study has four parts: Part A, Part B, Part C, and Part D.

The purpose of Part A of this study is to learn about the:

Read more
  • safety,
  • tolerability,
  • how PF-07293893 is processed by the body when multiple doses of PF-07293893 are given to healthy participants.

The purpose of Part B of this study is to understand the effect of multiple doses of PF-07393893 on the amount of midazolam when given as a single dose by mouth.

The purpose of part C of this study is to understand how PF-07293893 is changed in the body and how much PF-07293893 and it's changed forms are being removed in urine and feces after a single dose given to single participants.

The purpose of Part D is to understand the effect of multiple doses of PF-07293893 on the amount of glycogen (storage form of glucose) in the muscle of healthy participants.

Part B, C and D will be done if the results of Part A support further study of PF-07293893.

The study is seeking participants who:

  • are females who are not able to give birth to a child. These female participants should be between 18 to 65 years of age.
  • are males of 18 to 65 years of age.
  • have a body mass index (BMI) of 20.0 to 35.0 kilograms per squared meter.
  • have total body weight of more than 45 kilograms (99 pounds).

For a given participant in Part A, the total study is going to last up to about 11 weeks. This includes from the time of selection till the last follow-up phone call. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day 1 for around 18 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given.

For a given participant in Part B, the total study is going to last up to about 11 weeks. This study consists of 4 periods. Participants will be admitted to the study site on Day 1 and discharged on Day 3 in period 4. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine in period 4. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given in period 4.

For a given participant in Part C, the total study is going to last up to about 9 weeks. Participants will be admitted to the study site on Day 1. The participants will be discharged on Day 11 after giving the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given.

For a given participant in Part D, the total study is going to last up to about 11 weeks. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day -3 for around 17 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given.

Being tested
PF-07293893, Placebo, Midazolam
Keywords
PF-07293893, Multiple ascending dose, Safety, Tolerability, Pharmacokinetics

What participants receive

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

  • PF-07293893Drug

    PF-07293893 will be administered as tablets every day (QD) over 14 days

  • PlaceboDrug

    Placebo will be administered as tablets; QD over 14 days

  • MidazolamDrug

    Single doses of Midazolam will be administered as oral solution alone and in combination with PF-07293893

Study groups in NCT06177457
Study groupRoleWhat they receive
PF-07293893 and Placebo (Cohort 1)ExperimentalDose level 1: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo.
Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 2)ExperimentalDose level 2: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo.
Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 3)ExperimentalDose level 3: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo.
Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 4)ExperimentalDose level 4: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo.
Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 5)ExperimentalDose level 5: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo.
Receives: Drug: PF-07293893; Drug: Placebo
PF-07293893 and Placebo (Cohort 6, Optional)ExperimentalDose level 6: Multiple dose administration of PF-07293893 and placebo over 14 days in healthy participants; 6 participants will receive PF-07293893 and 2 will receive placebo.
Receives: Drug: PF-07293893; Drug: Placebo
Midazolam drug-drug interaction (Cohort 7, Optional)ExperimentalDrug-drug interaction assessment of pharmacokinetics interaction in PF-07293893 and midazolam
Receives: Drug: PF-07293893; Drug: Midazolam
Metabolism and elimination of PF-07293893 (Cohort 8, Optional)ExperimentalDetermination of excretion routes and metabolite profiling of PF-07293893.
Receives: Drug: PF-07293893
Skeletal muscle imaging (Cohort 8, optional)ExperimentalEvaluation of the effect of 14-days of daily PF-07293893 on skeletal muscle glycogen in healthy adult participants
Receives: Drug: PF-07293893; Drug: Placebo

What is being measured

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

  1. Part A:Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Measured: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks).

  2. Part A: Number of Participants With Clinical Laboratory Abnormalities

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).

  3. Part A: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).

  4. Part A: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).

  5. Part A: Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).

  6. Part A: Number of Participants With Clinically-Significant Change From Baseline in Neurological Examination Findings

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).

  7. Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose on Period 1/Day 1

  8. Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 36 hours post dose on Period 2/Day 2

  9. Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post dose on Period 4/Day 1

  10. Part B: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose on Period 1/Day 1

  11. Part B: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 36 hours post dose on Period 2/Day 2

  12. Part B: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post dose on Period 4/Day 1

  13. Part B: Area under the plasma concentration-time curve from time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose on Period 1/Day 1

  14. Part B: Area under the plasma concentration-time curve from time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 36 hours post dose on Period 2/Day 2

  15. Part B: Area under the plasma concentration-time curve from time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam

    Measured: Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post dose on Period 4/Day 1

  16. Part C: Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered.

    Measured: Predose to Day 11

  17. Part D: Change from baseline in glycogen on Day 14 as measured by 13C MRS of skeletal muscle

    Measured: Day 14 (last day of dosing)

Secondary outcomes (25)

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose on Day 1

  2. Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose on Day 14

  3. Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (tau) (AUCtau) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose on Day 1

  4. Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (tau) (AUCtau) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose on Day 14

  5. Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose on Day 1

  6. Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose on Day 14

  7. Part A: Amount of PF-07293893 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)

    Measured: On Day 14, urine collection for PK to occur over 0-tau, according to dosing frequency (ie, 0-12 hours for 12 hour dosing interval; 0-24 hours for 24 hour dosing interval)

  8. Part A: Percentage of Dose of PF-07293893 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)

    Measured: On Day 14, urine collection for PK to occur over 0-tau, according to dosing frequency (ie, 0-12 hours for 12 hour dosing interval; 0-24 hours for 24 hour dosing interval)

  9. Part A: Renal Clearance of PF-07293893

    Measured: On Day 14, urine collection for PK to occur over 0-tau, according to dosing frequency (ie, 0-12 hours for 12 hour dosing interval; 0-24 hours for QD dosing interval)

  10. Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Measured: Baseline up to 35 days after last dose of study intervention (approximately 10 weeks)

  11. Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)

  12. Part B: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)

  13. Part B: Number of Participants With Clinical Laboratory Abnormalities

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)

  14. Part B: Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings

    Measured: Baseline up to 35 days after last dose of study intervention (approximately 10 weeks)

  15. Part C: Maximum Observed Plasma Concentration (Cmax) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  16. Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  17. Part C: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  18. Part C: Area under the plasma concentration-time curve from time 0 to Extrapolated Infinite Time (AUCinf) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  19. Part C: Terminal half life (t1/2) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  20. Part C: Apparent clearance (CL/F) of PF-07293893 from plasma

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  21. Part C: Apparent volume of distribution (Vz/F) of PF-07293893

    Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post dose

  22. Part D: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Measured: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)

  23. Part D: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 8 weeks)

  24. Part D: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 8 weeks)

  25. Part D: Number of Participants With Clinical Laboratory Abnormalities

    Measured: Baseline up to 10 days after last dose of study intervention (approximately 8 weeks)

Timeline

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

  1. First posted20 Dec 2023
  2. Study start20 Dec 2023
  3. Primary completion2 Dec 2024
  4. Study completion2 Dec 2024

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
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06177457
Sponsor's protocol ID
C5171002
Other IDs
2023-508171-36-00, 2023
Status last verified
Dec 2024
First submitted
11 Dec 2023
Last updated
18 Dec 2024
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07293893 and Midazolam in people with Healthy Participants, run by Pfizer at 3 sites in 2 countries.

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 3 inclusion and 19 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Belgium. 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?

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?

Part A:Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks).). The study lists 17 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 NCT06177457.

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 18 Dec 2024.

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