A PhaseI Study to Evaluate the Safety, Tolerability and PK of AZD7442 - Covid-19 [COVID-19]
Research type
Research Study
Full title
A Phase 1 Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults.
IRAS ID
286622
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-003076-40
Duration of Study in the UK
1 years, 1 months, 19 days
Research summary
Summary of Research
This is a first human dose (FHD), Phase I, single centre, randomised, double-blinded, placebo controlled, dose escalating study evaluating the safety, tolerability, and pharmacokinetics (PK) of AZD7442 in approximately 48 healthy adults, aged 18 to 55 years.\n\nThe main purpose of the trial/study is to investigate the safety and tolerability of AZD7442 administered directly to a vein through a drip (intravenously [IV]), or by injection into a muscle (intramuscularly [IM]). In addition, the PK concentrations of AZD7442, amount of anti drug antibodies (ADA) present, and functional inhibition of active Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) in the blood; as well as the AZD7442 PK concentrations present in nasal fluid will be studied. PK refers to how the drug is taken up into and distrubuted throughout the body; broken down and finally removed from the body.\n\nThe study will comprise of four fixed dose cohorts (groups), each with 12 healthy participants that are randomised (randomly allocated to groups) so that for every ten receiving AZD7442, two will receive placebo (a substance that has no therapeutic effect and is used as a control in testing new drugs). The first cohort will receive an IM dose; while the remaining three cohorts will receive escalating IV doses of study drug. Additional cohorts with lower/intermediate/higher doses of AZD7442 may be included upon a Dose Escalation Committee (DEC) decision.\n\nThe total trial duration for the individual participant will be approximately 389 days. The trial includes a screening period of up to 27 days, residential period of 3 days (admission on the day before and discharge on the day after dosing), and a 360 day safety follow up period.\n\nAs this is the first study with AZD7442 in humans, no human safety data is available yet. Based on the non clinical safety data, no clinically significant undesirable effects are expected.\n\n
Summary of Results
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REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/1010
Date of REC Opinion
5 Aug 2020
REC opinion
Favourable Opinion