Finding studies
Finding studies
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Lead
AstraZeneca
This study comprises of 2 parts - Part A and Part B. Part A is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of repeated dosing of AZD5004 compared with placebo. Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo. Part A will comprise: 1. A Screening Period of maximum 28 days. 2. A Treatment Period of 106 days. 3. A final Follow-up Visit approximately 14 days after the last study intervention administration. Part B is a two-way cross-over study to compare the relative bioavailability of 2 oral tablet strengths of Formulation 1 (F1) of AZD5004. The purpose of this study is to expand product knowledge between the 2 oral tablet strengths on plasma exposure levels to guide Phase 3 drug product development. The participants will be split into 2 groups. Group 1 will be dosed with Treatment 1 of AZD5004 and then dosed with Treatment 2 of AZD5004. Group 2 will be dosed with Treatment 2 of AZD5004 and then dosed with Treatment 1 of AZD5004. Part B of the study will comprise: 1. A Screening Period of maximum 28 days. 2. Two Treatment Periods, each consisting of 7 days. 3. A final Follow-up Visit approximately 6 days after the last dose of study intervention administration.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
