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CompletedNCT06469151Updated Nov 10, 2025

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults

A Phase 1 interventional study of AZD5148 and Placebo in Healthy Participants, sponsored by AstraZeneca. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by AstraZeneca · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Healthy Participants

Keywords

  • Pharmacokinetics
  • Clostridioides difficile infection (CDI)
  • Placebo-controlled
  • Anti-drug antibodies (ADA)
03

In context

Clostridium Infections

310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.

This study's enrollment of 84 is above the median of 65 across 233 interventional studies indexed under Clostridium Infections.

Browse Clostridium Infections studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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:

    1. 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.
    2. 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):

    1. Participant with Chinese ancestry, born in mainland China, Hong Kong, or Taiwan.
    2. Participant is the descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents.
    3. Participant has lived outside China for ≤ 10 years at the time of Screening.
    4. Exhibits no significant change in lifestyle, including diet, since leaving China.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Cohort 1: AZD5148 (dose 1) IM

    Participants will receive AZD5148 (dose 1) or matching placebo as an IM injection

    Drug: AZD5148 · Drug: Placebo

  • Experimental
    Cohort 2a: AZD5148 (dose 2) IM

    Participants will receive AZD5148 (dose 2) or matching placebo as an IM injection

    Drug: AZD5148 · Drug: Placebo

  • Experimental
    Cohort 2b: AZD5148 (dose 2) IM

    Participants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection

    Drug: AZD5148 · Drug: Placebo

  • Experimental
    Cohort 3: AZD5148 (dose 2) IV

    Participants will receive AZD5148 (dose 2) or matching placebo as an IV bolus

    Drug: AZD5148 · Drug: Placebo

  • Experimental
    Cohort 4a: AZD5148 (dose 3) IV

    Participants will receive AZD5148 (dose 3) or matching placebo as an IV bolus

    Drug: AZD5148 · Drug: Placebo

  • Experimental
    Cohort 4b: AZD5148 (dose 3) IV

    Participants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus

    Drug: AZD5148 · Drug: Placebo

  • Experimental
    Cohort 5: AZD5148 (dose 4) IV

    Participants will receive AZD5148 (dose 4) or matching placebo as an IV bolus

    Drug: AZD5148 · Drug: Placebo

Interventions

  • DrugAZD5148

    Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus

  • DrugPlacebo

    Participants will receive matching doses of placebo as an IM injection or IV bolus

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Day -1 to Day 91

  2. 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.

    Time frame: From Screening (Day -28 to Day -1) to final Follow-up Visit (Day 361 ± 14)

Secondary outcomes

  1. Maximum observed drug concentration (Cmax)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  2. Time to reach maximum observed concentration (tmax)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  3. Time of last quantifiable concentration (tlast)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  4. Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  5. Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  6. Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  7. Volume of distribution at steady state (IV administration only) (Vss)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  8. Volume of distribution at terminal phase (IV administration only) (Vz)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  9. Systematic clearance (IV administration only) (CL)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  10. Apparent total body clearance (IM administration only) (CL/F)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  11. Apparent volume of distribution based on the terminal phase (IM administration only) (Vz/F)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  12. Bioavailability for extravascular administration (IM administration only) (F)

    To evaluate the single dose PK of AZD5148.

    Time frame: From Day 1 until last Follow up visit (Day 361 ± 14 days)

  13. Incidence of positive ADAs against AZD5148 in serum

    To evaluate the ADA responses to a single IV or IM dose of AZD5148.

    Time frame: Day 1 (pre-dose), Day 29, Day 91, Day 181 and Day 361

07

Study locations

4 sites
  • Research Site
    Anniston, Alabama 36207, United States
  • Research Site
    Glendale, California 91206, United States
  • Research Site
    Baltimore, Maryland 21225, United States
  • Research Site
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06469151
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Jun 24, 2024
Primary completion
Oct 22, 2025
Completion
Oct 22, 2025
Last update
Nov 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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