Clostridioides Difficile InfectionPhase 1NCT06639997
Safety and Tolerability of AZD5148 in Japanese Participants
A Phase 1 study testing AZD5148 in people with Clostridioides Difficile Infection, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridioides Difficile Infection
- 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
- 16 participants
- Where
- 1 siteJapan
- Study dates
- 31 Oct 2024to 25 Dec 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
- Participant must be Japanese male or female and aged 18-65 years inclusive at the time of signing the informed consent.
- Participants who are overtly healthy, as determined by medical evaluation, including medical history, physical examination and baseline safety laboratory studies, according to the judgement of the investigator.
- Electrocardiograms without clinically significant abnormalities at screening.
- Able to complete the Follow-up Period through Day 361 as required by the protocol.
- No medical history of symptomatic C. difficile infection within the prior 2 years.
- Participants must be medically stable, defined as disease not requiring significant change in therapy or hospitalisation or worsening disease during the 1 month prior to enrolment, with no acute change in condition at the time of study enrolment as judged by the Investigator.
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- Able to understand and comply with study requirements/procedures based on the assessment of the Investigator.
- Body weight within the range of 45 to 110 kg and body mass index (BMI) within the range of 18.0 to 32.0 kg/m2 (inclusive) at screening.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Women of no childbearing potential are defined as women who are either permanently sterilised or postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply:
- Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following the cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range.
- Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following the cessation of all exogenous hormonal treatment.
- Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Women of childbearing potential who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control from 3 months prior to IMP administration and agree to continue through 360 days following IMP administration. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, withdrawal, spermicides only and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of childbearing potential must have negative results of pregnancy tests prior to dosing.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Previous hypersensitivity, infusion-related reaction or severe adverse reaction following mAb administration.
- Abnormal vital signs after 5 minutes of supine rest, at Screening and/or admission to the study site.
- Any clinically important abnormalities in laboratory values at the Screening Visit.
- Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture
- Primary or acquired immunodeficiency, including HIV infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. Any known HIV infection at screening
- Any known hepatitis B or C virus infection at screening
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- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years
- Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results
- Absence of suitable veins for blood sampling and IMP administration
- Receipt of immunoglobulin or blood products, or expected receipt, within 6 months prior to screening or expected to receive during the study
- Previous receipt of an mAb within 6 months or five antibody half-lives (whichever is longer), prior to informed consent date
- Receipt of any investigational products in the preceding 90 days or expected receipt of investigational product during the period of study follow-up or concurrent participation in another interventional study
- Participants with a known hypersensitivity to any component of the IMP
- History of allergic disease or reactions likely to be exacerbated by any component of the IMP
- Blood drawn in excess of a total of 400 mL (1 unit) for any reason within 3 months prior to screening or plan to donate blood until the end of follow-up period
- History of alcohol or drug abuse within the past 2 years that, according to the investigator, might affect the assessments of safety or ability the of participant to comply with all study requirements
- Deprived of freedom by an administrative or court order, in an emergency setting or hospitalised involuntarily
- Any condition that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the IMP or interpretation of participant safety or study results. The investigator should follow the standard vital sign ranges
- Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restriction sand requirements.
- Previous randomisation in the present study.
- For females only - currently pregnant or breast-feeding.
- Employees of the sponsor, study site or any other individuals involved with the conduct of the study or immediate family members of such individuals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Japanese Adults
The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.
Read the detailed description
The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.
Study details include:
- There will be 12 planned visits (including screening visit) over a period of up to 56 weeks.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- AZD5148, Placebo
- 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 as 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 IM | Experimental | Biological: AZD5148 (Cohort 1)
・Single dose of AZD5148 IM Receives: Drug: AZD5148 |
| Cohort 1 - Placebo IM | Placebo comparator | Biological: Placebo (Cohort 1) Single dose of Placebo IM Receives: Drug: Placebo |
| Cohort 2 - AZD5148 IV | Experimental | Biological: AZD5148 (Cohort 2)
・Single dose of AZD5148 IV Receives: Drug: AZD5148 |
| Cohort 2 - Placebo IV | Placebo comparator | Biological: Placebo (Cohort 2) Single dose of Placebo IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Japanese participants with adverse events (AEs).
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Measured: From Randomization (Day -1 or Day 1) to Day 91
Number of participants with serious adverse events (SAEs)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Measured: From Screening (Day -28 to Day -2) to final Follow-up Visit (Day 361)
Number of participants with adverse events of special interest (AESIs)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Measured: From Randomization (Day -1 or Day 1) to final Follow-up Visit (Day 361)
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)
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 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 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 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 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 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 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 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 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 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 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 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 posted15 Oct 2024
- Study start31 Oct 2024
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639997
- Sponsor's protocol ID
- D8820C00005
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. 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 Japanese Adults
- ClinicalTrials.gov ID
- NCT06639997
- Acronym / sponsor ID
- D8820C00005
- Conditions
- Clostridioides Difficile Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 15 Oct 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 PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.
Detailed description
The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.
Study details include:
- There will be 12 planned visits (including screening visit) over a period of up to 56 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AZD5148 IM | Experimental | Drug: AZD5148Biological: AZD5148 (Cohort 1) ・Single dose of AZD5148 IM |
| Cohort 1 - Placebo IM | Placebo comparator | Drug: PlaceboBiological: Placebo (Cohort 1) Single dose of Placebo IM |
| Cohort 2 - AZD5148 IV | Experimental | Drug: AZD5148Biological: AZD5148 (Cohort 2) ・Single dose of AZD5148 IV |
| Cohort 2 - Placebo IV | Placebo comparator | Drug: PlaceboBiological: Placebo (Cohort 2) Single dose of Placebo IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participant must be Japanese male or female and aged 18-65 years inclusive at the time of signing the informed consent.
- Participants who are overtly healthy, as determined by medical evaluation, including medical history, physical examination and baseline safety laboratory studies, according to the judgement of the investigator.
- Electrocardiograms without clinically significant abnormalities at screening.
- Able to complete the Follow-up Period through Day 361 as required by the protocol.
- No medical history of symptomatic C. difficile infection within the prior 2 years.
Key exclusion criteria (22 listed)
- Previous hypersensitivity, infusion-related reaction or severe adverse reaction following mAb administration.
- Abnormal vital signs after 5 minutes of supine rest, at Screening and/or admission to the study site.
- Any clinically important abnormalities in laboratory values at the Screening Visit.
- Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture
- Primary or acquired immunodeficiency, including HIV infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. Any known HIV infection at screening
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 as IM injection or IV bolus | Drug | Cohort 1 - AZD5148 IM, Cohort 2 - AZD5148 IV |
| PlaceboParticipants will receive matching doses of placebo as an IM injection or IV bolus | Drug | Cohort 1 - Placebo IM, Cohort 2 - Placebo IV |
Primary outcome
Number of Japanese participants with adverse events (AEs).
Time frame: From Randomization (Day -1 or Day 1) to Day 91
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Number of participants with serious adverse events (SAEs)
Time frame: From Screening (Day -28 to Day -2) to final Follow-up Visit (Day 361)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
Number of participants with adverse events of special interest (AESIs)
Time frame: From Randomization (Day -1 or Day 1) to final Follow-up Visit (Day 361)
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
13 secondary outcomes
Maximum observed drug concentration (Cmax)
Time frame: From Day 1 until last Follow up visit (Day 361)
Time to reach maximum observed concentration (tmax)
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Time of last quantifiable concentration (tlast)
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz)
Time frame: From Day 1 until last Follow up visit (Day 361 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 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 days)
Volume of distribution at steady state (IV administration only) (Vss)
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Volume of distribution at terminal phase (IV administration only) (Vz)
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Systematic clearance (IV administration only) (CL)
Time frame: From Day 1 until last Follow up visit (Day 361 days)
Apparent total body clearance (IM administration only) (CL/F)
Time frame: From Day 1 until last Follow up visit (Day 361 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 days)
Bioavailability for extravascular administration (IM administration only) (F)
Time frame: From Day 1 until last Follow up visit (Day 361 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 30 Jan 2026.
- 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 shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5148 in people with Clostridioides Difficile Infection, run by AstraZeneca at 1 site in Japan.
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 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. 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 Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Japanese participants with adverse events (AEs). (time frame: From Randomization (Day -1 or Day 1) to Day 91). The study lists 3 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 30 Jan 2026.