Healthy ParticipantsPhase 1NCT06469151
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
A Phase 1 study testing AZD5148 in people with Healthy Participants, run by AstraZeneca at 4 sites in United States.
Trial summary
The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in 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?
- AZD5148
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jun 2024to 22 Oct 2025
- 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
- Healthy participants with suitable veins for cannulation or repeated venipuncture at the time of consent.
- All women must have a negative serum pregnancy test at the Screening Visit.
- Women of childbearing potential must have a negative urine pregnancy test on admission to the Clinical Unit.
- Women of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy from 3 months prior to administration of the study drug and until 360 days after the dose of the study drug.
- Women of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicular stimulating hormone (FSH) levels in the postmenopausal range.
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- Documentation of irreversible surgical sterilization by complete hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- Have a Body mass index ≥ 18.0 to ≤ 32.0 kg/m2 and weigh ≥ 45 kg and ≤ 110 kg.
- Willing and able to complete the Follow-up Period through Day 361.
- Healthy Chinese participants - participants of Chinese descent are eligible based on meeting all of the following specific criteria for these two cohorts (Cohorts 2b and 4b):
- Participant with Chinese ancestry, born in mainland China, Hong Kong, or Taiwan.
- Participant is the descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents.
- Participant has lived outside China for ≤ 10 years at the time of Screening.
- Exhibits no significant change in lifestyle, including diet, since leaving China.
Who cannot join
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study drug.
- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in previous 5 years.
- Any medical history of symptomatic CDI within the prior 2 years.
- Any clinically important abnormalities in laboratory values, vital signs, clinical chemistry, hematology, or urinalysis results.
- Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV).
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- Primary or acquired immunodeficiency, including HIV infection or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent within 6 months prior to Screening. Human immunodeficiency virus (HIV) testing must be negative at Screening Visit.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram, at Screening.
- Known or suspected history of alcohol or drug abuse within the past 2 years that might affect assessments of safety or ability of participant to comply with all study requirements.
- Positive screen for drugs of abuse, or alcohol at Screening or Day -1.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to the study drug.
- History of previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal antibodies (mAbs).
- Previous receipt of a mAb within 6 months, or 5 antibody half-lives (whichever is longer), prior to the start of the study.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- Receipt of immunoglobulin or blood products, or expected receipt, within 6 months prior to Screening or expected to receive during the study.
- Clinically significant bleeding disorder (e.g., factor VIII deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Anniston, Alabama, 36207
Research Site
Baltimore, Maryland, 21225
Research Site
Glendale, California, 91206
Research Site
San Antonio, Texas, 78229
About this study
Official title: A Phase I Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in healthy participants
Read the detailed description
This is a first in human study which will be conducted at four clinical units. Participants will be randomized to receive AZD5148, or placebo administered by intramuscular (IM) injection into the lateral thigh muscle or intravenous (IV) bolus (single, discrete dose of a drug).
This study will include 7 dose cohorts, two of which will include exclusively participants of Chinese descent, Cohort 2b and 4b. Each dose cohort will begin with a Sentinel Group of 2 participants randomized 1:1 (AZD5148:placebo). The participants in the Sentinel Group will undergo a safety monitoring period of 24 hours before the remaining participants in that cohort are dosed. If there would be no safety concerns, the remaining participants in the cohort will be dosed in a 9:1 ratio (AZD5148: placebo). Each participant will be involved in the study for up to 56 weeks (including Screening Period)
The study will comprise:
- A Screening Period of maximum 28 days (Day -28 to Day -1 inclusive).
- A Treatment and Follow-up Period lasting 12 months after the administration of the study drug.
- Participants will be resident at the Clinical Unit from the day before study drug administration (Day -1) until all assessments are completed on Day 2.
- A final Follow-up Visit will occur within 361 ± 14 days after the study drug administration.
- Conditions
- Healthy Participants
- Being tested
- AZD5148, Placebo
- Keywords
- Pharmacokinetics, Clostridioides difficile infection (CDI), Placebo-controlled, Anti-drug antibodies (ADA)
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5148Drug
Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus
PlaceboDrug
Participants will receive matching doses of placebo as an IM injection or IV bolus
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AZD5148 (dose 1) IM | Experimental | Participants will receive AZD5148 (dose 1) or matching placebo as an IM injection Receives: Drug: AZD5148; Drug: Placebo |
| Cohort 2a: AZD5148 (dose 2) IM | Experimental | Participants will receive AZD5148 (dose 2) or matching placebo as an IM injection Receives: Drug: AZD5148; Drug: Placebo |
| Cohort 2b: AZD5148 (dose 2) IM | Experimental | Participants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection Receives: Drug: AZD5148; Drug: Placebo |
| Cohort 3: AZD5148 (dose 2) IV | Experimental | Participants will receive AZD5148 (dose 2) or matching placebo as an IV bolus Receives: Drug: AZD5148; Drug: Placebo |
| Cohort 4a: AZD5148 (dose 3) IV | Experimental | Participants will receive AZD5148 (dose 3) or matching placebo as an IV bolus Receives: Drug: AZD5148; Drug: Placebo |
| Cohort 4b: AZD5148 (dose 3) IV | Experimental | Participants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus Receives: Drug: AZD5148; Drug: Placebo |
| Cohort 5: AZD5148 (dose 4) IV | Experimental | Participants will receive AZD5148 (dose 4) or matching placebo as an IV bolus Receives: Drug: AZD5148; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs).
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants.
Measured: From Day -1 to Day 91
Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants.
Measured: From Screening (Day -28 to Day -1) to final Follow-up Visit (Day 361 ± 14)
Secondary outcomes (13)
Maximum observed drug concentration (Cmax)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Time to reach maximum observed concentration (tmax)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Time of last quantifiable concentration (tlast)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Volume of distribution at steady state (IV administration only) (Vss)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Volume of distribution at terminal phase (IV administration only) (Vz)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Systematic clearance (IV administration only) (CL)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Apparent total body clearance (IM administration only) (CL/F)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Apparent volume of distribution based on the terminal phase (IM administration only) (Vz/F)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Bioavailability for extravascular administration (IM administration only) (F)
To evaluate the single dose PK of AZD5148.
Measured: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Incidence of positive ADAs against AZD5148 in serum
To evaluate the ADA responses to a single IV or IM dose of AZD5148.
Measured: Day 1 (pre-dose), Day 29, Day 91, Day 181 and Day 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start24 Jun 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469151
- Sponsor's protocol ID
- D8820C00002
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06469151
- Acronym / sponsor ID
- D8820C00002
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Clostridioides difficile infection (CDI), Placebo-controlled, Anti-drug antibodies (ADA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 21 Jun 2024 (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.
The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in healthy participants
Detailed description
This is a first in human study which will be conducted at four clinical units. Participants will be randomized to receive AZD5148, or placebo administered by intramuscular (IM) injection into the lateral thigh muscle or intravenous (IV) bolus (single, discrete dose of a drug).
This study will include 7 dose cohorts, two of which will include exclusively participants of Chinese descent, Cohort 2b and 4b. Each dose cohort will begin with a Sentinel Group of 2 participants randomized 1:1 (AZD5148:placebo). The participants in the Sentinel Group will undergo a safety monitoring period of 24 hours before the remaining participants in that cohort are dosed. If there would be no safety concerns, the remaining participants in the cohort will be dosed in a 9:1 ratio (AZD5148: placebo). Each participant will be involved in the study for up to 56 weeks (including Screening Period)
The study will comprise:
- A Screening Period of maximum 28 days (Day -28 to Day -1 inclusive).
- A Treatment and Follow-up Period lasting 12 months after the administration of the study drug.
- Participants will be resident at the Clinical Unit from the day before study drug administration (Day -1) until all assessments are completed on Day 2.
- A final Follow-up Visit will occur within 361 ± 14 days after the study drug administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: AZD5148 (dose 1) IM | Experimental | Drug: AZD5148, Drug: PlaceboParticipants will receive AZD5148 (dose 1) or matching placebo as an IM injection |
| Cohort 2a: AZD5148 (dose 2) IM | Experimental | Drug: AZD5148, Drug: PlaceboParticipants will receive AZD5148 (dose 2) or matching placebo as an IM injection |
| Cohort 2b: AZD5148 (dose 2) IM | Experimental | Drug: AZD5148, Drug: PlaceboParticipants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection |
| Cohort 3: AZD5148 (dose 2) IV | Experimental | Drug: AZD5148, Drug: PlaceboParticipants will receive AZD5148 (dose 2) or matching placebo as an IV bolus |
| Cohort 4a: AZD5148 (dose 3) IV | Experimental | Drug: AZD5148, Drug: PlaceboParticipants will receive AZD5148 (dose 3) or matching placebo as an IV bolus |
| Cohort 4b: AZD5148 (dose 3) IV | Experimental | Drug: AZD5148, Drug: PlaceboParticipants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus |
| Cohort 5: AZD5148 (dose 4) IV | Experimental | Drug: AZD5148, Drug: PlaceboParticipants will receive AZD5148 (dose 4) or matching placebo as an IV bolus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy participants with suitable veins for cannulation or repeated venipuncture at the time of consent.
- All women must have a negative serum pregnancy test at the Screening Visit.
- Women of childbearing potential must have a negative urine pregnancy test on admission to the Clinical Unit.
- Women of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy from 3 months prior to administration of the study drug and until 360 days after the dose of the study drug.
- Women of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
Key exclusion criteria (17 listed)
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study drug.
- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in previous 5 years.
- Any medical history of symptomatic CDI within the prior 2 years.
- Any clinically important abnormalities in laboratory values, vital signs, clinical chemistry, hematology, or urinalysis results.
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 |
|---|---|---|
| AZD5148Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus | Drug | Cohort 1: AZD5148 (dose 1) IM, Cohort 2a: AZD5148 (dose 2) IM, Cohort 2b: AZD5148 (dose 2) IM, Cohort 3: AZD5148 (dose 2) IV, Cohort 4a: AZD5148 (dose 3) IV, Cohort 4b: AZD5148 (dose 3) IV, Cohort 5: AZD5148 (dose 4) IV |
| PlaceboParticipants will receive matching doses of placebo as an IM injection or IV bolus | Drug | Cohort 1: AZD5148 (dose 1) IM, Cohort 2a: AZD5148 (dose 2) IM, Cohort 2b: AZD5148 (dose 2) IM, Cohort 3: AZD5148 (dose 2) IV, Cohort 4a: AZD5148 (dose 3) IV, Cohort 4b: AZD5148 (dose 3) IV, Cohort 5: AZD5148 (dose 4) IV |
Primary outcome
Number of participants with adverse events (AEs).
Time frame: From Day -1 to Day 91
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants.
Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: From Screening (Day -28 to Day -1) to final Follow-up Visit (Day 361 ± 14)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants.
13 secondary outcomes
Maximum observed drug concentration (Cmax)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Time to reach maximum observed concentration (tmax)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Time of last quantifiable concentration (tlast)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Volume of distribution at steady state (IV administration only) (Vss)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Volume of distribution at terminal phase (IV administration only) (Vz)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Systematic clearance (IV administration only) (CL)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Apparent total body clearance (IM administration only) (CL/F)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Apparent volume of distribution based on the terminal phase (IM administration only) (Vz/F)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Bioavailability for extravascular administration (IM administration only) (F)
Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)
Incidence of positive ADAs against AZD5148 in serum
Time frame: Day 1 (pre-dose), Day 29, Day 91, Day 181 and Day 361
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 10 Nov 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 AZD5148 in people with Healthy Participants, run by AstraZeneca at 4 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 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 adverse events (AEs). (time frame: From Day -1 to Day 91). 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 10 Nov 2025.