Safety and Tolerability of AZD5148 in Japanese Participants

NCT06639997 | Completed Phase 1

• 1 other identifier: D8820C00005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clostridioides Difficile Infection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From Randomization (Day -1 or Day 1) to final Follow-up Visit (Day 361)

Secondary Outcomes (13)

• Maximum observed drug concentration (Cmax)

  From Day 1 until last Follow up visit (Day 361)

• Time to reach maximum observed concentration (tmax)

  From Day 1 until last Follow up visit (Day 361 days)

• Time of last quantifiable concentration (tlast)

  From Day 1 until last Follow up visit (Day 361 days)

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

  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)

  From Day 1 until last Follow up visit (Day 361 days)

Study Arms (4)

Cohort 1 - AZD5148 IM

EXPERIMENTAL

Biological: AZD5148 (Cohort 1) ・Single dose of AZD5148 IM

Drug: AZD5148

Cohort 1 - Placebo IM

PLACEBO COMPARATOR

Biological: Placebo (Cohort 1) Single dose of Placebo IM

Drug: Placebo

Cohort 2 - AZD5148 IV

EXPERIMENTAL

Biological: AZD5148 (Cohort 2) ・Single dose of AZD5148 IV

Drug: AZD5148

Cohort 2 - Placebo IV

PLACEBO COMPARATOR

Biological: Placebo (Cohort 2) Single dose of Placebo IV

Drug: Placebo

Interventions

AZD5148 DRUG

Participants will receive AZD5148 as IM injection or IV bolus

Cohort 1 - AZD5148 IM; Cohort 2 - AZD5148 IV

Placebo DRUG

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

Cohort 1 - Placebo IM; Cohort 2 - Placebo IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Sumida-ku, 130-0004, Japan

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: October 31, 2024
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

JP (1)