Phase 1 trial to investigate PK of AZD6793 following Single and Multiple doses
Research type
Research Study
Full title
A Single-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of oral AZD6793 Following Single and Multiple Ascending Doses in Healthy Subjects
IRAS ID
1006418
Contact name
Cecilia Kristensson
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-002951-21
Clinicaltrials.gov Identifier
Research summary
This is a single-blind, randomised, placebo-controlled, two-part study to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD6793 in male and female healthy volunteers. The clinical trial medicine, AZD6793, works by inhibiting (stopping or slowing) the substance, IRAK4’s activity and therefore stopping or slowing the inflammation in the body.. AZD6793 will be administered in single oral doses (Part 1) and repeated doses (Part 2).
Each study part will include a screening visit, a treatment period and a final follow-up visit. Participants in Part 1 will stay 4 nights in house and receive the trial medicine once on Day 1. Participants in Part 2 will stay 10 nights inhouse and will receive the trial medicine on Day 1+8 once daily and on Day 3-7 twice daily. Eligible participants will remain residential at the Clinical Unit for the duration of the treatment period.
AZD6793 has not been studied in man previously. This is a first-in-human clinical trial to see how safe the study drug is and how well the body tolerates the study drug. Single doses at increasing dose levels will be administrated orally in 5 healthy subject cohorts. Repeated doses at increasing dose levels will be administered in 3 healthy subject cohorts.The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as PK). In addition, the study will investigate the anti-inflammatory effect as a measure of the effects of the study drug on the body (referred to as pharmacodynamics [PD])and the way in which the study drug works (mechanism of action).
The study drug is being developed by AstraZeneca, for treatment of patients with inflammatory diseases and systemic autoimmune diseases.REC name
London - Riverside Research Ethics Committee
REC reference
22/LO/0652
Date of REC Opinion
1 Dec 2022
REC opinion
Further Information Favourable Opinion