Phase 1 to assess Safety, Tolerability, PK & PD of AZD0780 in HV
Research type
Research Study
Full title
A Phase I, Randomized, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Single and Multiple Ascending Dose Administration to Healthy Subjects with or without Elevated LDL-C Levels
IRAS ID
1006041
Contact name
Venkat Chintapalli
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-002221-10
Clinicaltrials.gov Identifier
Research summary
This study is a multi-centre, randomised, single-blind, placebo-controlled study in approximately 132 healthy male and female (of non-childbearing potential) participants (56 participants in Part A and 76 participants in Part B) between the ages of 18 to 50 years old. Additional participants may be included for optional cohorts (groups), depending upon emerging data.
The new medicine tested in this clinical trial is a compound called AZD0780. AZD0780 has been developed by AstraZeneca AB for the treatment of Dyslipidemias. The main purpose of this first in human (FIH) trial is to examine how AZD0780 is taken up, metabolised (chemically broken down), distributed through the body and excreted from the body after single (Part A) and multiple (Part B) oral doses. The clinical trial will also see how safe AZD0780 is and how well tolerated it is after dosing.
The trial comprises a screening period of up to 28 days, one in-house stay of 4 days and one outpatient visit for Part A. For Part B, the trial comprises an optional pre-screening visit, a screening period of up to 28 days, one in-house stay of 30 days and either one or two outpatient visits (depending on the cohort). It is planned for Parexel London EPCU to only participate in Part B Global MAD cohorts to enrol 21 participants.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0225
Date of REC Opinion
25 Aug 2022
REC opinion
Further Information Favourable Opinion