Safety and Tolerability of AZD5148 in Japanese Participants

Inclusion Criteria

• •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.
• •1. 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.
• •2. 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.