dose exploration intramuscular/intravenous prophylaxis pharmacokinetic exposure response study

Conditions: COVID-19

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).

the study will be conducted in the united states of america. eligible healthy participants will be randomized to receive either azd3152 or placebo administered im or iv, across 5 fixed-dose cohorts. participants will receive a single dose of azd3152/placebo. cohort 1: dose x of azd3152 or placebo, as an im injection cohort 2: dose x of azd3152 or placebo, administered iv cohort 3: dose y of azd3152 or placebo, as an im injection cohort 4: dose y of azd3152 or placebo, administered iv cohort 5: dose z of azd3152 or placebo, administered iv the study will comprise of: * a screening period of maximum 28 days. * a treatment period of one day. * a follow-up period of 12 months after study intervention (day 365).

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.

Keywords: coronavirus disease 2019 (covid-19) prophylaxis setting