Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05872958
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female participants.
* Participants have suitable veins for cannulation or repeated venipuncture.
* Negative SARS-CoV-2 RT-PCR or SARS-CoV-2 rapid antigen test result at Visit 1.
* Body weight ≥ 45 kg and ≤ 110 kg and body mass index ≥ 18 and \<32 kg/m2 at Screening.
* Able to complete the Follow-up Period up to Day 365 as required by the protocol.
Exclusion Criteria:
* History of any clinically important disease or disorder.
* Receipt of any immunoglobulin (either COVID-19 or non-COVID related) or blood products within 6 months prior to Day 1.
* Receipt of an EVUSHELD monoclonal antibody (mAb) against SARS-CoV-2 within last 15 months before Day 1.
* Receipt of a COVID-19 vaccine within 14 days prior to Visit 1.
* SARS-CoV-2 infection within one month prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at-home testing\]).
* Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy,
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. This includes any acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the Screening Period or may be rescreened once.
* Any abnormal laboratory values as described in protocol.
* Any known HIV or hepatitis B or C infection at Screening.
* History of alcohol or substance abuse that in the opinion of the Investigator might interfere with the trial conduct or completion.
* Known hypersensitivity to AZD3152.
* Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05872958
Study Brief:
Protocol Section:
NCT05872958