A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
A Phase I Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
1 other identifier
interventional
84
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 21, 2024
CompletedStudy Start
First participant enrolled
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2025
CompletedNovember 10, 2025
November 1, 2025
1.3 years
June 17, 2024
November 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
From Screening (Day -28 to Day -1) to final Follow-up Visit (Day 361 ± 14)
Secondary Outcomes (13)
Maximum observed drug concentration (Cmax)
From Day 1 until last Follow up visit (Day 361 ± 14 days)
Time to reach maximum observed concentration (tmax)
From Day 1 until last Follow up visit (Day 361 ± 14 days)
Time of last quantifiable concentration (tlast)
From Day 1 until last Follow up visit (Day 361 ± 14 days)
Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz)
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)
From Day 1 until last Follow up visit (Day 361 ± 14 days)
- +8 more secondary outcomes
Study Arms (7)
Cohort 1: AZD5148 (dose 1) IM
EXPERIMENTALParticipants will receive AZD5148 (dose 1) or matching placebo as an IM injection
Cohort 2a: AZD5148 (dose 2) IM
EXPERIMENTALParticipants will receive AZD5148 (dose 2) or matching placebo as an IM injection
Cohort 2b: AZD5148 (dose 2) IM
EXPERIMENTALParticipants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection
Cohort 3: AZD5148 (dose 2) IV
EXPERIMENTALParticipants will receive AZD5148 (dose 2) or matching placebo as an IV bolus
Cohort 4a: AZD5148 (dose 3) IV
EXPERIMENTALParticipants will receive AZD5148 (dose 3) or matching placebo as an IV bolus
Cohort 4b: AZD5148 (dose 3) IV
EXPERIMENTALParticipants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus
Cohort 5: AZD5148 (dose 4) IV
EXPERIMENTALParticipants will receive AZD5148 (dose 4) or matching placebo as an IV bolus
Interventions
Participants will receive AZD5148 (dose 1, dose 2, dose 3 or dose 4) as an IM injection or IV bolus
Participants will receive matching doses of placebo as an IM injection or IV bolus
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 21, 2024
Study Start
June 24, 2024
Primary Completion
October 22, 2025
Study Completion
October 22, 2025
Last Updated
November 10, 2025
Record last verified: 2025-11
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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.