Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

• Status: Not yet recruiting
• Trial end date: 2024-10-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular [IM] injection and Intravenous [IV] infusion).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Healthy male or female participants with no co-morbidities.

• 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 <30 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 immunoglobulin (non-COVID related) or blood products within 6 months prior to Day 1.

• Receipt of an AZD7442 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 1 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.